Document:

Exhibit 10.5

 

BIOHORIZONS, INC.

 

EMPLOYEE STOCK PURCHASE PLAN

 

1.                                       Purpose of the Plan.  BioHorizons, Inc. (the “Company”) believes that ownership of shares of its common stock, par value $0.0001 per share (the “Common Stock”), by employees of the Company and its Participating Subsidiaries (as defined below) is desirable as an incentive to better performance and improvement of profits, and as a means by which employees may share in the rewards of growth and success.  The purpose of the Company’s Employee Stock Purchase Plan (the “Plan”) is to provide a convenient means by which employees of the Company and Participating Subsidiaries may purchase the Company’s shares through payroll deductions and a method by which the Company may assist and encourage such employees to become share owners.  It is the intention of the Company to have the plan qualify as an “Employee Stock Purchase Plan” under Section 423 of the Internal Revenue Code of 1986, as amended (the “Code”). The provisions of the Plan, accordingly, shall be constructed so as to extend and limit participation in a manner consistent with the requirements of that section of the Code.

 

2.                                       Shares Reserved for the Plan.  The maximum number of shares of Common Stock, which shall be made available for sale under the Plan shall be 100,000 shares,  plus an annual increase on the first day of each of the Company’s fiscal years beginning in 2012, equal to the lesser of (i) 50,000 shares, (ii) one percent of the shares of Common Stock outstanding on the last day of the immediately preceding fiscal year, or (iii) such lesser number of shares as is determined by the Board of Directors, subject to adjustment upon changes in capitalization of the Company as provided in paragraph 18.  If the total number of shares which would otherwise be subject to options granted pursuant to paragraph 5(b) on the Offering Date of an Offering exceeds the number of shares then available under the Plan (after deduction of all shares for which options have been exercised), the Company shall make a pro rata allocation of the shares remaining available for option grants in as uniform a manner as shall be practicable and as it shall determine to be equitable.  Any amounts remaining in an Employee’s account not applied to the purchase of shares of Common Stock pursuant to this paragraph 2 shall be refunded on or promptly after the Purchase Date.  In such event, the Company shall give written notice of such reduction of the number of shares of Common Stock subject to the option to each Employee affected thereby.

 

3.                                       Administration of the Plan.  The Plan shall be administered by or under the direction of the Compensation Committee of the Board of Directors, which may delegate some or all of its duties and authority to one or more Company employees. The Compensation Committee may adopt, amend and rescind rules and regulations deemed desirable or appropriate for the operation of the Plan, adopt forms for use in connection with the Plan, construe and interpret the Plan or rights arising thereunder, and make all other determinations necessary or advisable for the administration of the Plan.  The Compensation Committee may consult with counsel for the Company on any matter arising under the Plan.  All determinations and decisions of the Compensation Committee shall be conclusive.

 

4.                                       Eligible Employees.  All Eligible Employees (as defined below) of the Company, BioHorizons Implant Systems, Inc. and each corporate subsidiary of the Company that is designated

 

 

by the Board of Directors of the Company as a participant in the Plan (such participating subsidiary being hereinafter called a “Participating Subsidiary”) are eligible to participate in the Plan.  An “Eligible Employee” is an employee who is in the active service of the Company or a Participating Subsidiary on the applicable Subscription Deadline (as defined below) excluding, however, (a) any employee whose customary employment is less than 20 hours per week and less than 5 months per year, and (b) any employee who would, after a purchase of shares under the Plan, own or be deemed (under Section 424(d) of the Code) to own stock (including stock subject to any outstanding options held by the employee) possessing 5 percent or more of the total combined voting power or value of all classes of stock of the Company or any parent or subsidiary of the Company.

 

5.                                       Offerings.

 

(a)                                  Offering and Purchase Dates.  The Plan shall be implemented by a series of six-month offerings (the “Offerings”), with a new Offering commencing on January 1 and July 1 of each year or the first business day thereafter (or at such other time or times as may be determined by the Board) and shall end on June 30 and December 31 of that year or the first business day thereafter.  The first day of each Offering is the “Offering Date” for that Offering and the last day of each Offering is the “Purchase Date” for that Offering.  The first Offering Date shall be at a time to be determined by the Compensation Committee.

 

(b)                                 Grants; Limitations.  On each Offering Date, each Eligible Employee shall be granted an option under the Plan to purchase shares of Common Stock on the Purchase Date for the Offering for the price determined under paragraph 7 of the Plan exclusively through payroll deductions authorized under paragraph 6 of the Plan; provided, however, that (i) no option shall permit the purchase of more than 5,000 shares of Common Stock, and (ii) no option may be granted under the Plan that would allow an employee’s right to purchase shares under all stock purchase plans of the Company and its parents and subsidiaries to which Section 423 of the Code applies to accrue at a rate that exceeds $25,000 of fair market value of shares (determined at the date of grant) for each calendar year in which such option is outstanding.

 

6.                                       Participation in the Plan.

 

(a)                                  Initiating Participation.  An Eligible Employee may elect to participate in an Offering under the Plan by completing a subscription agreement authorizing payroll deductions.  The subscription and payroll deduction authorization must be filed no later than the “Subscription Deadline,” which shall be a number of days prior to the Offering Date with the exact number of days being established from time to time by the Compensation Committee by written notice to Eligible Employees.  Once filed, a subscription and payroll deduction authorization shall remain in effect unless amended or terminated, and upon the expiration of an Offering the participants in that Offering will be automatically enrolled in the new Offering starting the following day.  The payroll deduction authorization will authorize the employing corporation to make payroll deductions in an amount designated by the participant from each of the participant’s paychecks during the Offering.  The designated amount to be deducted from each paycheck may not be less than 1% or more than 10% of the participant’s Compensation (as defined below) for the period covered by the paycheck.  If payroll deductions are made by a Participating Subsidiary, that corporation will promptly remit the amount of the deductions to the Company.

 

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(b)                                 Definition of Compensation.  “Compensation” means the participant’s pay reportable on IRS Form W-2 (under Section 3401(a) of the Code), adjusted as follows:

 

(i)                                     Before-tax contributions to a non-qualified deferred compensation arrangement, contributions to a plan qualified under Section 401(k) of the Code, and any amounts set aside by the participant from otherwise taxable pay under a welfare benefit plan qualified under Section 125 of the Code shall be included.

 

(ii)                                  Expense reimbursements, disability benefits, payments from a nonqualified deferred compensation arrangement, stock option income, and adjustments for overseas employment (other than any transfer premium) shall be excluded.

 

(iii)                               Any payment representing excess vacation or paid time-off accruals (where such excess represents vacation or time-off not taken) shall be excluded.

 

(c)                                  Amending Participation.  After a participant has begun participating in the Plan by initiating payroll deductions, the participant may amend the payroll deduction authorization (i) once during any Offering to decrease the amount of payroll deductions, and (ii) effective for the first paycheck of a new Offering to either increase or decrease the amount of payroll deductions.  A permitted change in payroll deductions shall be effective for any pay period only if notice is received by the Company at least some number of days prior to the payday for that pay period, with the exact number of days being established from time to time by the Compensation Committee by written notice to participants.  Notwithstanding the foregoing, if the amount of payroll deductions from any participant during an Offering exceeds the maximum amount that can be applied to purchase shares in that Offering under the limitations set forth in paragraph 5(b) above, then (x) as soon as practicable following a request from the participant, payroll deductions from the participant shall cease and all such excess amounts shall be refunded to the participant, and (y) payroll deductions from the participant shall restart as of the commencement of the next Offering at the rate set forth in the participant’s then effective payroll deduction authorization.

 

(d)                                 Terminating Participation.  After a participant has begun participating in the Plan by initiating payroll deductions, the participant may terminate participation in the Plan by notifying the Company at least some number of days prior to a Purchase Date, with the exact number of days being established from time to time by the Compensation Committee by written notice to participants.  Participation in the Plan shall also terminate when a participant ceases to be an Eligible Employee for any reason, including death or retirement.  A participant may not reinstate participation in the Plan with respect to a particular Offering after once terminating participation in the Plan with respect to that Offering.  Upon termination of a participant’s participation in the Plan, all amounts deducted from the participant’s Compensation and not previously used to purchase shares under the Plan shall be returned to him or her, or, in the case of his or her death, to the person or persons entitled thereto under paragraph 12, and his or her option will be automatically terminated.

 

7.                                       Option Price.  The price at which shares shall be purchased in an Offering shall be the lower of (a) 85% of the fair market value of a share of Common Stock on the Offering Date of the Offering or (b) 85% of the fair market value of a share of Common Stock on the Purchase Date of the Offering.  The fair market value of a share of Common Stock on any date shall be (i) if the

 

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Common Stock is listed on a national securities exchange or traded in the over-the-counter market and sales prices are regularly reported for the Common Stock, the closing or last sale price of the Common Stock for such date (or, in the event that the Common Stock is not traded on such date, on the immediately preceding trading date), on the composite tape or other comparable reporting system; or (ii) if the Common Stock is not listed on a national securities exchange and such price is not regularly reported, the mean between the bid and asked prices per share of the Common Stock at the close of trading in the over-the-counter market.

 

8.                                       Purchase of Shares.  All amounts withheld from the Compensation of a participant shall be credited to his or her account under the Plan.  No interest will be paid on such accounts, unless otherwise determined by the Board of Directors.  On each Purchase Date, the amount of the account of each participant will be applied to the purchase of shares by such participant from the Company at the price determined under paragraph 7 above. If a fractional number of shares results, then such number shall be rounded down to the next whole number and any unapplied cash from the fractional share shall be carried forward to the next Purchase Date, unless the participant requests a cash payment. Any other cash balance remaining in a participant’s account after a Purchase Date including as a result of the limitations set forth in paragraph 5(b) above shall be returned to the participants as promptly as possible.

 

9.                                       Delivery and Custody of Shares.  Upon the written request of a participant, certificates representing the shares purchased by participants pursuant to the Plan will be issued as promptly as practicable after the Purchase Date of each Offering to participants who wish to hold their shares in certificate form except that the Compensation Committee may determine that such shares shall be held for each participant’s benefit by a broker designated by the Compensation Committee.

 

10.                                 Records and Statements.  The Custodian will maintain the records of the Plan.  As soon as practicable after each Purchase Date each participant will receive a statement showing the activity of his or her account since the preceding Purchase Date and the balance on the Purchase Date as to both cash and shares. Participants will be furnished such other reports and statements, and at such intervals, as the Compensation Committee shall determine from time to time.

 

11.                                 Expense of the Plan.  The Company will pay all expenses incident to operation of the Plan, including costs of record keeping, accounting fees, legal fees, commissions and issue or transfer taxes on purchases pursuant to the Plan, and on delivery of shares to a participant or into his or her brokerage account.  The Company will not pay expenses, commissions or taxes incurred in connection with sales of shares by the Custodian at the request of a participant.  Expenses to be paid by a participant will be deducted from the proceeds of sale prior to remittance.

 

12.                                 Designation of Beneficiary.

 

(a)                                  A participant may designate a beneficiary who is to receive any shares and cash, if any, from the participant’s account under the Plan in the event of such participant’s death subsequent to the Purchase Date but prior to delivery to him or her of such shares and cash.  In addition, a participant may designate a beneficiary who is to receive any cash from the participant’s account under the Plan in the event of such participant’s death prior to the Purchase Date.  If a

 

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participant is married and the designated beneficiary is not the spouse, spousal consent shall be required for such designation to be effective.  Beneficiary designations shall be made either in writing or by electronic delivery as directed by the Company.

 

(b)                                 Such designation of beneficiary may be changed by the participant (and his or her spouse, if any) at any time by submission of the required notice, which may be electronic.  In the event of the death of a participant and in the absence of a beneficiary validly designated under the Plan who is living at the time of such participant’s death, the Company shall deliver such shares and/or cash to the executor or administrator of the estate of the participant, or if no such executor or administrator has been appointed (to the knowledge of the Company), the Company, in its discretion, may deliver such shares and/or cash to the spouse or to any one or more dependents or relatives of the participant, or if no spouse, dependent or relative is known to the Company, then to such other person as the Company may designate.

 

13.                                 Transferability.  The right to purchase shares under this Plan is not transferable by a participant, and such right is exercisable during the participant’s lifetime only by the participant. Any such attempt at assignment, transfer, pledge or other disposition shall be without effect, except that the Company may treat such act as an election to terminate participation in accordance with paragraph 6(d).

 

14.                                 Voting and Shareholder Communications.  In connection with voting on any matter submitted to the shareholders of the Company, the Custodian will cause the shares held by the Custodian for each participant’s accounts to be voted in accordance with instructions from the participant or, if requested by a participant, furnish to the participant a proxy authorizing the participant to vote the shares held by the Custodian for his or her accounts.  Copies of all general communications to shareholders of the Company will be sent to participants in the Plan.

 

15.                                 Tax Withholding. In the event that the Company or any Subsidiary is required to withhold any Federal, state, local or foreign taxes in respect of any compensation or other income realized by the Participant, the Company or such Subsidiary may deduct from any payments of any kind otherwise due to such Participant, including without limitation the proceeds of any sale of Common Stock for the account of the Participant, the aggregate amount of such Federal, state, local or foreign taxes required to be withheld or, if such payments are insufficient to satisfy such Federal, state, local or foreign taxes, the Participant will be required to pay to the Company or such Subsidiary, or make other arrangement satisfactory to the Company or such Subsidiary regarding payment to the Company or such Subsidiary of, the aggregate amount of any such taxes.

 

16.                                 Responsibility and Indemnity.  Neither the Company, its Board of Directors, the Compensation Committee, the Custodian, any Participating Subsidiary, nor any member, officer, agent, or employee of any of them, shall be liable to any participant under the Plan for any mistake of judgment or for any omission or wrongful act unless resulting from gross negligence, willful misconduct or intentional misfeasance.  The Company will indemnify and save harmless its Board of Directors, the Compensation Committee, the Custodian and any such member, officer, agent or employee against any claim, loss, liability or expense arising out of the Plan, except such as may result from the gross negligence, willful misconduct or intentional misfeasance of such entity or person.

 

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17.                                 Conditions and Approvals.  The obligations of the Company under the Plan shall be subject to compliance with all applicable state and federal laws and regulations, compliance with the rules of any stock exchange on which the Company’s securities may be listed, and approval of such federal and state authorities or agencies as may have jurisdiction over the Plan or the Company. The Company will use its best effort to comply with such laws, regulations and rules and to obtain such approvals.

 

18.                                 Adjustments Upon Changes in Capitalization.

 

(a)                                  Subject to any required action by the Company’s stockholders, the number of shares of Common Stock covered by unexercised options under the Plan and the number of shares of Common Stock which have been authorized for issuance under the Plan but are not yet subject to options under paragraph 2, the maximum number of shares of Common Stock that may be purchased by a participant set forth in paragraph 5(b), as well as the price per share of Common Stock covered by each unexercised option under the Plan, may be proportionately adjusted for any increase or decrease in the number of issues shares of Common Stock resulting from a stock split, reverse stock split, stock dividend, combination or reclassification of the Common Stock. The determination of whether an adjustment shall be made and the manner of any such adjustment shall be made by the Board of Directors of the Company, which determination shall be conclusive.

 

(b)                                 In the event of the proposed dissolution or liquidation of the Company, an Offering then in progress will terminate immediately prior to the consummation of such proposed action, unless otherwise provided by the Board of Directors.  In the event of a proposed sale of all or substantially all of the assets of the Company, or the merger, consolidation or other capital reorganization of the Company with or into another corporation, each option outstanding under the Plan shall be assumed or an equivalent option shall be substituted by such successor corporation or a parent or subsidiary of such successor corporation, unless the Board of Directors determines, in the exercise of its sole discretion and in lieu of such assumption or substitution, to shorten the Offering then in progress by setting a new Purchase Date (the “New Purchase Date”).  If the Board of Directors shortens the Offering then in progress in lieu of assumption or substitution in the event of a merger or sale of assets, the Board of Directors shall notify each participant in writing, at least ten days prior to the New Purchase Date, that the Purchase Date for his or her option has been changed to the New Purchase Date and that his or her option will be exercised automatically on the New Purchase Date, unless prior to such date he or she has withdrawn from the Offering as provided in paragraph 6(d).  For purposes of this paragraph, an option granted under the Plan shall be deemed to be assumed if, following the sale of assets, merger or other reorganization, the option confers the right to purchase, for each share of Common Stock subject to the option immediately prior to the sale of assets, merger or other reorganization, the consideration (whether stock, cash or other securities or property) received in the sale of assets, merger or other reorganization by holders of Common Stock for each share of Common Stock held on the effective date of such transaction (and if such holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding shares of Common Stock); provided, however, that if such consideration received in such transaction was not solely common stock of the successor corporation or its parent (as defined in Section 424(e) of the Code), the Board of Directors may, with the consent of the successor corporation, provide for the consideration to be received upon exercise of the option to be solely common stock of the successor corporation or its parent equal in fair market value to the per share

 

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consideration received by holders of Common Stock in the sale of assets, merger or other reorganization.

 

(c)                                  The Board of Directors may, if it so determines in the exercise of its sole discretion, also make provision for adjusting the number of shares of Common Stock which have been authorized for issuance under the Plan but are not yet subject to options under paragraph 2, as well as the price per share of Common Stock covered by each outstanding option, in the event that the Company effects one or more reorganizations, recapitalizations, rights offerings or other increases or reductions of shares of its outstanding Common Stock, and in the event of the Company being consolidated with or merged into any other corporation.

 

19.                                 Amendment and Termination of the Plan.  The Board of Directors of the Company may from time to time amend or terminate the Plan. Except as provided in paragraphs 2 or 18, no such termination may affect options previously granted, nor may an amendment make any change in any option theretofore granted which adversely affects the rights of any participant provided that an Offering may be terminated by the Board of Directors on a Purchase Date or by the Board of Director’s setting a new Purchase Date with respect to an Offering then in progress if the Board of Directors determines that termination of the Offering is in the best interests of the Company and the stockholders or if continuation of the Offering would cause the Company to incur adverse accounting charges in the generally-accepted accounting rules applicable to the Plan.  In addition, to the extent necessary to comply with Section 423 of the Code (or any successor rule or provision or any applicable law or regulation); the Company shall obtain stockholder approval in such a manner and to such a degree as so required. Without stockholder consent and without regard to whether any participant rights may be considered to have been adversely affected, the Board of Directors shall be entitled to change the Offerings, limit the frequency and/or number of changes in the amount withheld during an Offering, establish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars, permit payroll withholding in excess of the amount designated by a participant in order to adjust for delays or mistakes in the Company’s processing of properly completed withholding elections, establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Stock for each participant properly correspond with amounts withheld from the participant’s Compensation, and establish such other limitations or procedures as the Board of Directors determines in its sole discretion advisable that are consistent with the Plan.

 

20.                                 Term of Plan.  The Plan became effective the date on which the Securities and Exchange Commission declared the Registration Statement effective and shall continue in effect for a term of twenty years unless sooner terminated under paragraph 19.

 

21.                                 Right to Terminate Employment. Nothing in the Plan or in any agreement entered into pursuant to the Plan shall confer upon any Eligible Employee the right to continue in the employment of the Company or any subsidiary, or affect any right which the Company or any subsidiary may have to terminate the employment of the Eligible Employee.

 

22.                                 Information Regarding Disqualifying Dispositions.  By electing to participate in the Plan, each participant agrees to provide any information about any transfer of shares of Common Stock acquired under the Plan that occurs within two years after the first business day of the Offering

 

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in which such shares were acquired as may be requested by the Company or any Subsidiaries in order to assist it in complying with the tax laws.

 

23.                                 Rights as a Stockholder.  Neither the granting of an option nor a deduction from payroll shall constitute an Employee the owner of shares covered by an option. No Employee shall have any right as a stockholder unless and until an option has been exercised, and the shares underlying the option have been registered in the Company’s share register.

 

24.                                 Applicable Law.  This Plan shall be governed in accordance with the laws of the State of Delaware, applied without giving effect to any conflict-of-law principles.

 

8Exhibit 10.14

 

AMENDED AND RESTATED SERVICE CONTRACT

 

THIS AMENDED AND RESTATED SERVICE CONTRACT (the “Agreement ) is made effective as of January 1, 2011 (the “Effective Date”) between Quality Tech Services, Inc., a Minnesota corporation having a place of business at 10525 Hampshire Avenue South, Suite 600, Bloomington, MN 55438 (“QTS”) and BioHorizons, Inc. a Delaware corporation having a place of business at 2300 Riverchase Center, Birmingham, AL 35244, on behalf of itself and its affiliates, (“BioHorizons” and together with QTS, the “Parties”).

 

WHEREAS, the Parties are parties to a Service Contract, executed on April 7, 2004, as amended and supplemented to date (the “Prior Agreement”), pursuant to which QTS provides services to BioHorizons; and

 

WHEREAS, the Parties desire to enter into this Agreement, which amends, restates and supersedes the Prior Agreement in its entirety;

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

1.     SERVICES; EXCLUSIVITY; SPECIFICATIONS.

 

1.1       QTS agrees, subject to the terms and conditions of this Agreement, to provide the services described on Exhibit A (the “Services”) to BioHorizons for the products (the “Products”) set forth on Exhibit A during the Term.

 

1.2       BioHorizons agrees that, except as provided in Section 1.1, during the Term one hundred percent (100%) of BioHorizons’ requirements for Services for the Products will be provided by QTS and QTS agrees to provide all of BioHorizons’ requirements for Services for the Products during the Term.

 

1.3       Services will conform to the specifications provided by BioHorizons to QTS from time to time (the “Specifications”).  BioHorizons shall have the right in its sole discretion to update or change the Specifications from time to time with regard to any Service or any Product on thirty (30) days written notice, on any Purchase Order, Engineering Drawing or Inspection and Process Control Criteria.  BioHorizons will provide QTS with current revision documents. Purchase Order revision levels take precedence over all other documents. However, if there arises any conflict between this Agreement and any other agreement, purchase orders or related agreements, this Agreement shall govern.

 

1.4       In the event that any change to the Specifications, including but not limited to, rush orders, changes in irradiation/lab fees, changes in injection molded component prices, changes in packaging materials, or if BioHorizons supplied materials require additional and/or special storage, cleaning, inspection or handling result in a change in costs to QTS, QTS will notify BioHorizons of such cost change in writing with as much advanced notice as is reasonable and will propose a new price. No price change may be implemented without the written consent of both Parties. If the Parties cannot agree on the price for Services based on the change in Specifications or other change, or cannot mutually agree on any other provision of this Agreement that requires mutual agreement of the Parties, within 30 days of the notice from QTS to BioHorizons of the proposed change, the Parties shall be relieved of their obligations under Section 1.1 or 1.2 with respect to the related Services, subject to the terms of Section 13.2.1.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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2.     DEVIATIONS.  QTS agrees to notify BioHorizons and obtain written approval prior to any deviation from or modification to the Product, process or equipment affecting form, fit or function of Products.

 

3.     FORECASTS.  BioHorizons shall furnish QTS with a good faith, 12 month rolling forecast of the estimated quantities of Services for each Product that BioHorizons intends to purchase from QTS during the average month of the upcoming four (4) calendar quarters (the “Forecast”).  The initial forecast as of the Effective Date is attached as Exhibit B. Notwithstanding the foregoing, BioHorizons shall notify QTS of any revision to a Forecast already furnished to QTS as soon as commercially practicable after BioHorizons becomes aware that it is likely or actual requirements have materially changed.  It is understood that the quantities specified in the Forecasts are intended to be estimates only and shall not be binding on BioHorizons.

 

4.     PRICING and VOLUME DISCOUNTS.  QTS agrees to perform services on BioHorizons products as listed in Exhibit A. Exhibit A may be modified in writing by mutual agreement of the parties from time-to-time.

 

5.     REDUNDANCY.  The Parties shall work together to prepare a written plan, and to update the plan from time to time, that specifies the specific steps to be taken to provide the redundancy necessary if an event renders QTS unable to provide the Services to BioHorizons required by this Agreement.

 

6.     PRODUCT IDENTIFICATION AND TRACEABILITY.  QTS agrees to provide systems to ensure component and material traceability for each BioHorizons process by establishing and maintaining documented procedures:

 

6.1          For identifying the Product from receipt through all stages of production and delivery;

 

6.2          For unique identification of individual Product or batches.

 

6.3          To use only approved material or service vendors; and

 

6.4          To notify BioHorizons of pending material lot number changes if multi-lot use will be required.

 

7.     PROCESS CONTROL.  QTS shall identify and plan the production and servicing processes mutually agreed to between BioHorizons and QTS, which directly affect quality and shall ensure that these processes are carried out under controlled conditions.  Controlled conditions shall include:

 

7.1          documented procedures defining the manner of production;

 

7.2          use of suitable production equipment and a suitable working environment;

 

7.3          compliance with Quality Requirements Specifications (provided with purchase order and detailed in the QTS Manufacturing Procedures) (the “Quality Requirements Specification”);

 

7.4          monitoring and control of suitable process parameters;

 

7.5          the approval of processes and equipment, as appropriate;

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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7.6          assigning only trained, qualified personnel to perform manufacturing operations for Products;

 

7.7          criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples, or illustrations); and

 

7.8          suitable maintenance of equipment to ensure continuing process capability.

 

8.     INSPECTION AND TEST STATUS.  QTS shall identify the inspection and test status of Product or materials mutually agreed to between BioHorizons and QTS , which indicate the conformance or non-conformance of Product with regard to inspection and test performed.  QTS shall maintain the identification of inspection and test status, as defined in documented procedures mutually agreed to between BioHorizons and QTS.

 

9.     INSPECTION AND TESTING.  QTS shall establish and maintain documented procedures for inspection and testing activities in order to verify that the Specifications for the Product are met. QTS shall provide BioHorizons with documentation of all such procedures mutually agreed to between BioHorizons and QTS.

 

9.1          Receiving inspection and testing.  QTS shall ensure that incoming materials are not used or processed until it has been inspected or otherwise verified as conforming to specified requirements. Verification of the specified requirements shall be in accordance with documented procedures.

 

9.2          In-process inspection and testing.  QTS shall:

 

9.2.1       Inspect and test the Product/package as required by the Quality Requirements Specifications and/or documented procedures;

 

9.2.2       Hold Product until the required inspection and tests have been completed or necessary reports have been received and verified.

 

9.3          Final inspection and testing.

 

9.3.1       QTS shall carry out all final inspection and testing in accordance with the Quality Requirements Specifications and/or documented procedures to complete the evidence of conformance of the finished Product/package to the specified requirements.

 

9.3.2       QTS’s documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either upon receipt of material or in-process, have been carried out and that the results meet specified requirements.

 

9.3.3       No Product shall be shipped by QTS until all the activities specified in the Quality Requirements Specifications and/or documented procedures have been satisfactory completed and the associated data and documentation are available and authorized.

 

9.4          Inspection and test records.  QTS shall establish and maintain records, which provide evidence that the Product/package has been inspected and/or tested.  These records shall show clearly whether the Product has passed or failed the inspection and/or tests according to defined acceptance criteria.  Where the Product fails to pass any inspection and/or test, the procedures for control of non-

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

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conforming Product shall apply.  Records shall identify the inspection authority responsible for the release of Product.

 

9.5          Gamma Radiation Sterilization Services.  QTS agrees to qualify, maintain, and utilize only (a) QTS-approved provider(s) of gamma radiation sterilization services for BioHorizons Product, and to require that sterilization of BioHorizons Product by any such provider be procedurally documented and performed in conformance with section 9.4.3 of ISO 11137-1:2006, Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, or superseding equivalent standard.

 

10.  CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT

 

10.1        QTS shall establish and maintain documented procedures to control, calibrate, and maintain inspection, measuring and test equipment used by QTS to demonstrate the conformance of Product/package to the specified requirements.  Inspection, measuring and test equipment shall be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

 

10.2        QTS and BioHorizons shall mutually agree on:

 

10.2.1     the measurements to be made and the accuracy required, and select the appropriate inspection, measuring, and test equipment that is capable of the necessary accuracy and precision; and

 

10.2.2     all inspection, measuring and test equipment that can affect Product quality.

 

11.  CONTROL OF NONCONFORMING PRODUCT

 

11.1        General.  QTS shall establish and maintain documented procedures to ensure that the Product/package that does not conform to specified requirements is prevented from unintended use.  This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming Product, and for notification to the function concerned.

 

11.2        Review and Disposition of Nonconforming Product.  The responsibility for review and authority for the disposition of nonconforming Product shall be defined.  Nonconforming Product shall be reviewed in accordance with documented procedures.  It may be:

 

11.2.1     Reworked to meet specified requirements, the rework performed must be documented and accepted/approved by BioHorizons;

 

11.2.2     Accepted with or without repair by concession;

 

11.2.3     Re-graded for alternative applications; or

 

11.2.4     Scrapped.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

4

 

11.3        Repaired and/or reworked Product shall be re-inspected in accordance with the Quality Requirements Specifications and/or documented procedures.

 

12.  RECORDS.

 

12.1        QTS shall provide BioHorizons access to: Manufacturing Processes, Test/Inspection Records, Inspection Procedures, Calibration Records, Traceability Records and Non-Conformance Reports specific to BioHorizons Products.

 

12.2        QTS shall allow BioHorizons to perform facility audits on mutually agreeable frequency and times and agrees to establish corrective action programs if required.  Where BioHorizons is contractually obligated to do so, QTS shall allow a third party auditor to perform facility audits in conjunction with BioHorizons.

 

12.3        QTS shall provide the required certifications (as outlined on purchase orders) with all Products and Services stating conformance to all purchase order Specifications.

 

12.4        QTS agrees to maintain for five (5) years all records (excluding records supplied to BioHorizons) needed to demonstrate compliance to BioHorizons purchase orders, specifications and contracts.  Prior to disposing of records QTS shall notify BioHorizons and request concurrence that the records may be destroyed or turn the records over to BioHorizons for maintenance and disposition.

 

13.  TERMS AND CONDITIONS.

 

13.1        Invoices and Charges.  QTS will invoice BioHorizons for processing services rendered by QTS.  Payment of each invoice shall be made by BioHorizons net 30 days of the date of receipt of such invoice.  Any amount not so paid shall accrue simple interest at a rate of 11⁄2% per month from the date of the original invoice for such amount.  In the event BioHorizons fails to timely pay any invoice for services rendered, QTS reserves the right, at its option and upon notification of BioHorizons, to: (i) refuse to perform further services for BioHorizons, (ii) perform further services for BioHorizons only on a COD basis, (iii) withhold the shipment of Product in QTS’ possession until all past due invoices are paid, and/or (iv) make use of any other remedies legally available to it.  In addition to any amounts owed for services rendered, BioHorizons shall also reimburse QTS for any costs incurred in asserting its rights hereunder, including reasonable attorneys’ fees.

 

13.2        Performance of Processing Services

 

13.2.1       Processing Requirements.  QTS shall process Products in accordance with the parameters of the then current revision of the Manufacturing Procedures.  In the event that BioHorizons wishes to revise its commitment, cancel orders, suspend orders out beyond 30 days of original due date, or terminate the Agreement, BioHorizons agrees to purchase all inventory of materials, components and devices as well as all work-in-process at QTS. These purchases will be done at QTS’ fully burdened cost and in addition BioHorizons will pay all charges actually imposed by QTS’ suppliers that result from cancellation of such orders.  QTS will take

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

5

 

reasonable steps if and when possible to avoid such additional expenses being charged to BioHorizons.

 

13.2.2     Validation of Processing Requirements.  The Food and Drug Administration requires, and BioHorizons agrees, that BioHorizons shall have exclusive responsibility for the validation of processing requirements for Products prior to the commencement of commercial distribution of such Products.  BioHorizons acknowledges and agrees that it is solely and exclusively responsible for the validation of processing, Product sterility, integrity of Product packaging and the adequacy of Product labeling.

 

13.2.3      Shipment of the Products by QTS.  QTS shall cause the Products to be shipped in accordance with BioHorizons’ written instructions or Individual Manufacturing Procedures.  QTS is not responsible for any shipping damage or delay once the Products are shipped from QTS’ facility.  BioHorizons may choose to pay QTS to secure freight insurance on their behalf to cover potential shipping damage. When shipping the Products (FOB Origin, Freight Prepaid & Charged Back), QTS shall include documents specifying the name of the Products, the number of units of the Products, and the lot number.  QTS will also conspicuously mark the shipment to show its “non-sterile” or “sterile” nature with all shipping and handling costs to be borne by BioHorizons.

 

13.2.4      Storage of the Products or Materials by QTS.  QTS shall store the Products/materials on its premises provided BioHorizons has adequate insurance protecting all the Products/materials while in QTS’ control and while in transit to and from QTS, from any loss, casualty, or damage.  QTS shall conspicuously label all property of BioHorizons as such, shall not permit any lien to be placed on any BioHorizons property and shall notify BioHorizons promptly in writing in the event that any third party attempts to place a lien on any BioHorizons property.

 

BioHorizons acknowledges and agrees that in the event QTS has purchased materials (pouches, labels, boxes, etc.) for BioHorizons and BioHorizons obsoletes those materials and/or cancels such order, BioHorizons will be responsible for all costs associated with such materials. QTS REQUIRES FORMAL NOTICE WHENEVER REPROCESSED OR BIOCONTAMINATED DEVICES OR INSTRUMENTS ARE BEING SHIPPED TO QTS’ FACILITY.

 

BioHorizons agrees to list in their specifications documents or in the Exhibit A any and all storage concerns or special conditions of storage of BioHorizons’ products/materials. In addition, if the BioHorizons requests that QTS store more than five (5) pallets (or 400 cubic feet) of the Product and packaging materials, BioHorizons agrees to pay QTS for the additional storage at a mutually agreed to fee.

 

BioHorizons’ product and related materials warehoused at QTS that does not turn (i.e., be completely replaced) within six (6) months, will be

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

6

 

subject to additional storage fees mutually agreed to via the Exhibit A Price Schedule.

 

13.2.5      Compliance with Laws. Each of the Parties agrees at all times to conduct its operations in compliance with the applicable requirements of 21 CFR Part 801.150 (“Medical Devices: Processing, Labeling or Repacking”), 21 CFR Part 820 (“Quality System Regulation: General”), or any successor regulations as well as any other applicable laws and regulations.

 

13.3        Limited Warranty; Liability for Product Damage; Warranty Disclaimer; Limitation of Liability

 

13.3.1     Limited Warranty. QTS warrants to BioHorizons that it will process the Products in accordance with the parameters referred to in the then current revision of the Manufacturing Procedures and in accordance with QTS’ quality policy manual in effect when the Products are processed.  Notwithstanding the foregoing warranty, BioHorizons acknowledges that many factors beyond QTS’ control can affect the ultimate microbiological condition of the Products.  Among these are the quality, type and original bioburden of the Products and their packaging, the configuration of the Products, the material or construction of the Products, the adequacy of the testing laboratory atmosphere and equipment, the competence of testing laboratory atmosphere and equipment, the competence of testing laboratory personnel, the competence and adequacy of sampling techniques, and the care and handling of the Products during distribution. BioHorizons acknowledges that the foregoing limited warranty is personal to BioHorizons and that such limited warranty may be enforced against QTS only by BioHorizons, and not by any third party (including, without limitation, Product resellers and end-users).

 

13.3.2      If QTS becomes aware (either based on a notice from BioHorizons or otherwise) of any non-conformity with the limited warranty given in Section 13.3.1 (either through its own investigation or through written notice of BioHorizons) within ninety (90) days of shipment from QTS of the Products subject to the warranty claim, then BioHorizons’ exclusive remedy, and QTS’ sole liability to BioHorizons, shall be limited to;

 

	
(i)
  	
reprocessing such Products at QTS’ expense if the Products are not damaged, or
  
	
 
  	
 
  
	
(ii)
  	
if the Products are damaged, indemnifying BioHorizons for its direct manufacturing cost of any of the Products which are damaged by the processing nonconformance and which need to be replaced, up to a maximum payment per damaged Product equal to three (3) times the processing cost for such Product. QTS will reprocess such Products only after receiving written authorization from BioHorizons to do so.
  

 

 

13.3.3   Product Damage Caused By QTS.  If a Product is damaged by QTS as a result of physical mishandling by QTS, then BioHorizons’ exclusive

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

7

 

remedy, and QTS sole liability to BioHorizons, shall be limited to the amount set forth in Section 12.3.2 (ii).  BioHorizons will make every effort to keep cost to a minimum by refurbishing and/or repackaging wherever feasible. BioHorizons must present a written request to QTS for reimbursement for damages under this clause of the Agreement within thirty (30) days of the damage occurrence or lose its indemnification rights with respect to the damaged Products.  QTS will provide compensation to BioHorizons within thirty (60) days of written notification, provided the damages are not in dispute.

 

13.3.4   Warranty Disclaimer.  QTS makes no representation, guaranty or warranty, express or implied, other than the limited warranty contained in section 13.3.1.  In particular, QTS makes no representation, guarantee or warranty, express or implied, concerning the sterility of the Products or degree or sterilization, nor as to the merchantability or fitness for a particular purpose of Products after processing by QTS.

 

13.3.5   Limitation of Liability.  In no event shall QTS be liable for any special, indirect, incidental, consequential, punitive or other similar damages, including damages arising from death, bodily injury, property damage (other than damage to the Products as provided in section 13.3.2, loss of profits or revenue or loss of use of the Products. Subject to the requirements of section 13.3.3, QTS’ aggregate liability under or as a result of this agreement shall not exceed the gross proceeds received from BioHorizons during the calendar year when the incident giving rise to QTS’ liability occurs.

 

13.4        Term and Termination

 

13.4.1    This Agreement shall commence on the Effective Date and remain in force until December 31, 2012 (the “Initial Term”).  After the Initial Term, this Agreement shall be renewed automatically for successive one year periods unless BioHorizons or QTS provides written notice to the other Party, at least 90 days prior to the end of the Initial Term or any renewal term that the Agreement shall not be renewed.

 

13.4.2    Termination For Default.  If either Party is in material default of its obligations under this Agreement, the other Party may give written notice that the Agreement will be terminated if the default is not cured within thirty (30) days. If such notice is given and the default is not cured during the thirty (30) day period, then the Party not in default shall have the right to immediately terminate this Agreement.

 

13.4.3    Termination Upon Insolvency.  This Agreement shall be terminated effective immediately upon delivery of written notice by either Party of such termination if any of the following occurs: (i) the institution by or against a Party of insolvency, receivership or bankruptcy proceedings, (ii) such Party’s making an assignment for the benefit of creditors, or (iii) the dissolution of such Party. There shall be no opportunity to “cure” nor

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

8

 

any requirement for advance notice of termination under this section 13.4.3.

 

13.4.4

 

13.5        General Provisions

 

13.5.1    Governing Law.  The validity, construction, interpretation and enforcement of this Agreement, or any breach thereof shall be governed by the laws of the State of the defendant of record, applicable to contracts made and to be performed in that State.

 

13.5.2    Indemnification by BioHorizons. BioHorizons agrees to indemnify, hold harmless and defend QTS from and against all settlements, judgments, fines, expenses, losses, costs, deficiencies, liabilities and damages, including reasonable attorneys’ fees and expenses (collectively, “damages”) incurred or suffered by QTS arising out of or in connection with any act or omission of BioHorizons.

 

13.5.3    Indemnification by QTS.  QTS agrees to indemnify, hold harmless and defend BioHorizons from and against all damages incurred or suffered by BioHorizons arising out of or in connection with any act or omission of QTS.

 

13.5.4    Entire Agreement.  This Agreement constitutes the final written expression of the terms of agreement between the Parties relating to the subject matter contained herein and is the complete and exclusive statements of those terms. This Agreement supersedes all prior agreements with respect to such subject matter, including the Prior Agreement, which is hereby amended, restated and superseded in its entirety by this Agreement, and merges all prior discussion between the Parties.  All references to this Agreement shall be deemed to include the schedules hereto. No provision in any purchase order or purchase order confirmation, whether entered into prior to, concurrently with or after the execution and delivery of this Agreement, shall be effective to the extent that provision is inconsistent with any provision of this Agreement.

 

13.5.5    Amendments.  This Agreement may be amended only with the consent of both Parties in writing signed by an authorized representative of each Party.

 

13.5.6    Severability.  The provisions of this Agreement shall be deemed severable, and the invalidity, unenforceability or illegality of any provision of this Agreement shall not in any way affect or impair the validity, enforceability or legality of the other provisions hereof.

 

13.5.7    No Waiver.  The failure of either Party at any time to require performance by the other Party of any provision of this Agreement shall in no way affect the right of such Party to require performance of that provision, and any waiver by either Party of any breach of any provision of this Agreement shall not be construed as a waiver of any continuing or

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

9

 

	
 
  	
succeeding breach of such provision, a waiver of the provision itself or a waiver of any right under this Agreement.
  
	
 
  	
 
  
	
13.5.8
  	
Relationship. Each Party to this Agreement is an independent contractor, and nothing contained herein shall be construed to create an agency relationship between the Parties.
  
	
 
  	
 
  
	
13.5.9
  	
Force Majeure. Neither Party shall be responsible for any loss, damages or penalty resulting from delay in processing or delivery when such delay is due to causes beyond the reasonable control of such Party, including but not limited to, labor unrest, utility interruptions, shortages, riots, insurrection, fires, flood, storm, earthquake, explosion, act of God, war, terrorism, or governmental action.
  
	
 
  	
 
  
	
13.5.10
  	
Insurance. BioHorizons shall maintain at all times during the term of the Agreement, adequate insurance protecting all the Products/materials while in QTS’ control, and in BioHorizons’s case while in transit to and from QTS or QTS’ subcontractors, from any loss, casualty, or damage. BioHorizons shall maintain Product liability insurance resulting from use of the Products. QTS will maintain commercial general liability coverage ($3 Million per occurrence/ $4 Million aggregate) including completed operations ($3 Million per occurrence/ $3 Million aggregate). BioHorizons must have insurance to cover product recalls.
  
	
 
  	
 
  
	
13.5.11
  	
Product Withdrawal. If it is deemed necessary at any time by either BioHorizons or any authorized third party, regulatory or governmental agency to recall or withdraw from the market any quantity of any of BioHorizons’s Products subject to this Agreement, either as a result of failure of the Products or otherwise, BioHorizons shall bear all costs and expenses incurred by it and/or its distributors, if any, in complying with the recall or withdrawal procedures (including without limitation, costs of notifying customers, customer refunds, costs of returning product, loss profits, and other expenses incurred to meet obligations to third parties), unless (and only then to the extent) such recall or withdrawal is solely the result of the negligence or misconduct by QTS subject to the limitation of liability set forth in Section 13.3.5 above.
  
	
 
  	
 
  
	
13.5.12
  	
Non-Solicitation of Employees. Neither Party shall, for a period of twenty-four (24) months following the expiration or earlier termination of this Agreement, hire or employ, or attempt or offer to hire or employ, as a full-time or part-time employee, consultant, independent contractor or otherwise, any person employed by the other Party at any time during the term of this Agreement, without the written consent of the other Party. The terms and conditions of this subparagraph l shall survive the termination of this Agreement.
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

10

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the date first written below.

 

 

	
BIOHORIZONS, INC.
  	
 
  
	
 
  	
 
  
	
 
  	
 
  
	
/s/ J. Todd Strong  1/5/2011
  	
 
  
	
By:
  	
 
  
	
 
  	
 
  
	
J. Todd Strong
  	
 
  
	
Printed:
  	
 
  
	
 
  	
 
  
	
COO
  	
 
  
	
Its:
  	
 
  
	
 
  	
 
  
	
 
  	
 
  
	
QUALITY TECH SERVICES, INC.
  	
 
  
	
 
  	
 
  
	
 
  	
 
  
	
/s/ Doug Wilder   12/27/2010
  	
 
  
	
By:
  	
 
  
	
 
  	
 
  
	
Doug Wilder
  	
 
  
	
Printed:
  	
 
  
	
 
  	
 
  
	
President/CEO
  	
 
  
	
Its:
  	
 
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

11

 

QTS

Packaging Solutions

 

BioHorizons

Effective January 1, 2011

BIO 008 Rev 28

 

EXHIBIT A

 

	
Product
 Code
  	
 
  	
Description
  	
 
  	
Qty Range
  	
 
  	
$ Price 2011
  	
 
  
	
013J
  	
 
  	
Non-Sterile Prosthetics (Bulk Zip Lock Bag)
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  
	
013B
  	
 
  	
All Prosthetics (in Support Tub) 2-Phase
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
 
  	
 
  	
SYTPHA30 (in Support Tub) 2-Phase
  	
 
  	
 
  	
 
  	
$
  	
[***]
  	
 
  
	
0139
  	
 
  	
Single Stage Implants, 50 Pack 
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
013E
  	
 
  	
External Implants, 50 Packs
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
013F
  	
 
  	
Internal Implants, 50 Pack
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
013K
  	
 
  	
Tapered Internal Implants, 50 Pack
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
013L
  	
 
  	
One-Piece Implants, 50 Pack
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
013V
  	
 
  	
Micro-Lok Implants, 50 Pack
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
013W
  	
 
  	
**Mountless Tapered Internal Implants, 50 Pack 
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
 
  	
 
  	
With cleaning (TL 4607,4609,5807,5809)
  	
 
  	
 
  	
 
  	
$
  	
[***]
  	
 
  
	
1132
  	
 
  	
**Laser Lok 3.0 Implants, 50 Pack
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
1133
  	
 
  	
Internal Simple Solutions Abut w/ Laser Lok
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
1134
  	
 
  	
Single-stage Simple Solutions Abut Packs
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  
	
1135
  	
 
  	
Overdenture Implants
  	
 
  	
[***]
  	
 
  	
$
  	
[***]
  	
 
  

 

Validations and Procedure Development are project specific.

General guidelines:  Develop Manufacturing Procedures minimum $[***], Revise Existing Manufacturing Procedures minimum $[***], Initiate & Document Process Deviations $[***].

Gamma Stat 24 hours $[***]/one tote

Gamma Stat 48 hours $[***]/one tote

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

	
 
  	
BIO 008 Rev 28
  
	
 
  	
Page 1
  

 

 

QTS

Packaging Solutions

 

Materials:             (Included in unit price)

This quotation is based on QTS providing the required packaging materials. QTS is ordering packaging materials based on historical volumes at the request of BioHorizons.  BioHorizons will reimburse QTS for materials ordered specifically for BioHorizons in the event they are not utilized, obsoleted or do not “turn” at least [***] ([***]) times per calendar year.

 

Lot Fees:               [***]

 

Shipping & Handling:        [***]

 

Terms:                   Net 30 Day

 

Routine Sterilization:

 

[***] for routine runs when implants or prosthetics exceed [***] units.

For runs between [***] there will be a $[***] sterilization charge.

For all runs less than [***] there will be a sterilization fee of $[***].

[***].

 

*An effort will be made to include the tray packages with your new packaging scenarios in sterilization runs (i.e. QTS would cover the sterilization fees). However variations in densities may dictate processing separately and or creating additional dose maps.  Any additional sterilization, dose maps or processing requirements will be assessed an additional fee following approval by BioHorizons.

 

Miscellaneous:

Prices are based on BioHorizons providing QTS with a purchase order to cover packaging and shipping fees associated with processing the order. Prices take effect on orders processed after January 1st, 2011.

 

Volume Discount Units Purchased:

The parties agree that QTS will reduce unit prices across all product lines by the percentages noted below on future orders (in 2011 & 2012) once the units purchased and paid for exceed quantities listed below (implants and/or prosthetics)

 

	
QTY
  	
 
  	
Percent Discount
  	
 
  
	
[***]
  	
 
  	
[***]
  	
 
  
	
[***]
  	
 
  	
[***]
  	
%
  
	
[***]
  	
 
  	
[***]
  	
%
  
	
[***]
  	
 
  	
[***]
  	
%
  

 

*The discount is calculated off the Exhibit A price contained in this quotation.

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

	
 
  	
BIO 008 Rev 28
  
	
 
  	
Page 2
  

 

 

QTS

Packaging Solutions

 

*Provided total revenue received from BioHorizons exceeds $[***].

 

In the event that any change to the Specifications, including but not limited to rush orders, increases in irradiation/lab fees, increases in injection molded component prices, increases in packaging materials, or if BioHorizons supplied materials require additional and/or special storage, cleaning, inspection or handling result in additional costs to QTS, QTS will notify BioHorizons of such additional cost in writing with as much advanced notice as is reasonable and will propose prices that will be mutually agreed to by both parties.

 

 

	
/s/ Doug Wilder
  	
 
  	
/s/ J. Todd Strong
  
	
Signature
  	
 
  	
Signature
  
	
 
  	
 
  	
 
  
	
Doug Wilder
  	
 
  	
J. Todd Strong
  
	
Print    12/27/2010
  	
 
  	
Print    1/5/2011
  
	
 
  	
 
  	
 
  
	
President / CEO
  	
 
  	
COO
  
	
Quality Tech Services, Inc.
  	
 
  	
BioHorizons
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

	
 
  	
BIO 008 Rev 28
  
	
 
  	
Page 3
  

 

 

EXHIBIT B

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
1001
  	
 
  	
Micro-Lok 3.45mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
2001
  	
 
  	
Micro-Lok 4.0mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5001
  	
 
  	
Micro-Lok 5.0mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
10032
  	
 
  	
Micro-Lok 3.45 x 2mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
10034
  	
 
  	
Micro-Lok 3.45 x 4mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
10042
  	
 
  	
Micro-Lok 3.45 x 2mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
10043
  	
 
  	
Micro-Lok 3.45 x 3mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
20042
  	
 
  	
Micro-Lok 4.0 x 2mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
20044
  	
 
  	
Micro-Lok 4.0 x 4mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
20062
  	
 
  	
Micro-Lok 4.0 x 2mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
20063
  	
 
  	
Micro-Lok 4.0 x 3mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50052
  	
 
  	
Micro-Lok 5.0 x 2mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50054
  	
 
  	
Micro-Lok 5.0 x 4mm Straight Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50062
  	
 
  	
Micro-Lok 5.0 x 2mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50063
  	
 
  	
Micro-Lok 5.0 x 3mm Emergence Profile Healing Head
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
103-700
  	
 
  	
External 3.5mm Short Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
103-900
  	
 
  	
External 3.5mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
104-700
  	
 
  	
External 4.0mm Short Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
104-900
  	
 
  	
External 4.0mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
105-700
  	
 
  	
External 5.0mm Short Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
105-900
  	
 
  	
External 5.0mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
106-700
  	
 
  	
External 6.0mm Short Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
106-900
  	
 
  	
External 6.0mm Cover Screw
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-303
  	
 
  	
External 3.5mm x 3mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-304
  	
 
  	
External 3.5mm x 4.5mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-306
  	
 
  	
External 3.5mm x 6mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-403
  	
 
  	
External 4.0mm x 3mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-404
  	
 
  	
External 4.0mm x 4.5mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-406
  	
 
  	
External 4.0mm x 6mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-503
  	
 
  	
External 5.0mm x 3mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-504
  	
 
  	
External 5.0mm x 4.5mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-506
  	
 
  	
External 5.0mm x 6mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-603
  	
 
  	
External 6.0mm x 3mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-604
  	
 
  	
External 6.0mm x 4.5mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
204-606
  	
 
  	
External 6.0mm x 6mm Straight Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-303
  	
 
  	
External 3.5mm x 3mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-304
  	
 
  	
External 3.5mm x 4.5mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-306
  	
 
  	
External 3.5mm x 6mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-403
  	
 
  	
External 4.0mm x 3mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-404
  	
 
  	
External 4.0mm x 4.5mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-406
  	
 
  	
External 4.0mm x 6mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-503
  	
 
  	
External 5.0mm x 3mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-504
  	
 
  	
External 5.0mm x 4.5mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-506
  	
 
  	
External 5.0mm x 6mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-603
  	
 
  	
External 6.0mm x 3mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
212-604
  	
 
  	
External 6.0mm x 4.5mm Flared Healing 
  	
 
  	
Support 
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
Abutment
  	
 
  	
Tray
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
212-606
  	
 
  	
External 6.0mm x 6mm Flared Healing Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
223-208
  	
 
  	
External 3.5mm Abutment for Cement, Non-hexed
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
224-208
  	
 
  	
External 4.0mm Abutment for Cement, Non-hexed
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
225-208
  	
 
  	
External 5.0mm Abutment for Cement, Non-hexed
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
253-103
  	
 
  	
External 3.5mm Abutment for Screw, 3mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
253-104
  	
 
  	
External 3.5mm Abutment for Screw, 4mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
253-105
  	
 
  	
External 3.5mm Abutment for Screw, 5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
254-103
  	
 
  	
External 4.0mm Abutment for Screw, 3mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
254-104
  	
 
  	
External 4.0mm Abutment for Screw, 4mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
254-105
  	
 
  	
External 4.0mm Abutment for Screw, 5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
273-000
  	
 
  	
External 3.5mm PEEK Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
274-000
  	
 
  	
External 4.0mm PEEK Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
275-000
  	
 
  	
External 5.0mm PEEK Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
276-000
  	
 
  	
External 6.0mm PEEK Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3012OS2
  	
 
  	
Overdenture Implant 3.0 x 12mm, 2mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3012OS4
  	
 
  	
Overdenture Implant 3.0 x 12mm, 4mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3015OS2
  	
 
  	
Overdenture Implant 3.0 x 15mm, 2mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3015OS4
  	
 
  	
Overdenture Implant 3.0 x 15mm, 4mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3018OS2
  	
 
  	
Overdenture Implant 3.0 x 18mm, 2mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3018OS4
  	
 
  	
Overdenture Implant 3.0 x 18mm, 4mm Collar RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3507D3
  	
 
  	
External Implant RBT, D3 Threadform 3.5 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3509D3
  	
 
  	
External Implant RBT, D3 Threadform 3.5 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
35105D3
  	
 
  	
External Implant RBT, D3 Threadform 3.5 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
3512D3
  	
 
  	
External Implant RBT, D3 Threadform 3.5 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
3515D3
  	
 
  	
External Implant RBT, D3 Threadform 3.5 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4007D3
  	
 
  	
External Implant RBT, D3 Threadform 4.0 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4007D4
  	
 
  	
External Implant HA, D4 Threadform 4.0 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4009D3
  	
 
  	
External Implant RBT, D3 Threadform 4.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4009D4
  	
 
  	
External Implant HA, D4 Threadform 4.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
40105D3
  	
 
  	
External Implant RBT, D3 Threadform 4.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
40105D4
  	
 
  	
External Implant HA, D4 Threadform 4.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4012D3
  	
 
  	
External Implant RBT, D3 Threadform 4.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4012D4
  	
 
  	
External Implant HA, D4 Threadform 4.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4015D3
  	
 
  	
External Implant RBT, D3 Threadform 4.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
4015D4
  	
 
  	
External Implant HA, D4 Threadform 4.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5007D3
  	
 
  	
External Implant RBT, D3 Threadform 5.0 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5007D4
  	
 
  	
External Implant HA, D4 Threadform 5.0 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5009D3
  	
 
  	
External Implant RBT, D3 Threadform 5.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5009D4
  	
 
  	
External Implant HA, D4 Threadform 5.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50105D3
  	
 
  	
External Implant RBT, D3 Threadform 5.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
50105D4
  	
 
  	
External Implant HA, D4 Threadform 5.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5012D3
  	
 
  	
External Implant RBT, D3 Threadform 5.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5012D4
  	
 
  	
External Implant HA, D4 Threadform 5.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5015D3
  	
 
  	
External Implant RBT, D3 Threadform 5.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
5015D4
  	
 
  	
External Implant HA, D4 Threadform 5.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6007D3
  	
 
  	
External Implant RBT, D3 Threadform 6.0 x 7mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6007D4
  	
 
  	
External Implant HA, D4 Threadform 6.0 x 
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
7mm
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
6009D3
  	
 
  	
External Implant RBT, D3 Threadform 6.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6009D4
  	
 
  	
External Implant HA, D4 Threadform 6.0 x 9mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
60105D3
  	
 
  	
External Implant RBT, D3 Threadform 6.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
60105D4
  	
 
  	
External Implant HA, D4 Threadform 6.0 x 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6012D3
  	
 
  	
External Implant RBT, D3 Threadform 6.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6012D4
  	
 
  	
External Implant HA, D4 Threadform 6.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6015D3
  	
 
  	
External Implant RBT, D3 Threadform 6.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
6015D4
  	
 
  	
External Implant HA, D4 Threadform 6.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS353
  	
 
  	
External 3.5mm Abutment for Screw, 3.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS354
  	
 
  	
External 3.5mm Abutment for Screw, 4.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS355-17
  	
 
  	
External Abutment for Screw, 3.5 x 5mm, 17 Degree Angle
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS403
  	
 
  	
External 4.0mm Abutment for Screw, 3.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS404
  	
 
  	
External 4.0mm Abutment for Screw, 4.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS405-15
  	
 
  	
External Abutment for Screw, 4.0 x 5mm, 15 Degree Angle
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS405-25
  	
 
  	
External Abutment for Screw, 4.0 x 5mm, 25 Degree Angle
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS503
  	
 
  	
External 5.0mm Abutment for Screw, 3.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS504
  	
 
  	
External 5.0mm Abutment for Screw, 4.5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
AFS505-15
  	
 
  	
External Abutment for Screw, 5.0 x 5mm, 15 Degree Angle
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS310
  	
 
  	
Micro-Lok 3.45 x 10mm Implant 3.45 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS312
  	
 
  	
Micro-Lok 3.45 x 11.5mm Implant 3.45 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS313
  	
 
  	
Micro-Lok 3.45 x 13mm Implant 3.45 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS315
  	
 
  	
Micro-Lok 3.45 x 15mm Implant 3.45 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS408
  	
 
  	
Micro-Lok 4.0 x 8mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
IHPSS410
  	
 
  	
Micro-Lok 4.0 x 10mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS412
  	
 
  	
Micro-Lok 4.0 x 11.5mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS413
  	
 
  	
Micro-Lok 4.0 x 13mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS415
  	
 
  	
Micro-Lok 4.0 x 15mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS508
  	
 
  	
Micro-Lok 4.75 x 8mm Implant 5.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS510
  	
 
  	
Micro-Lok 4.75 x 10mm Implant 5.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS512
  	
 
  	
Micro-Lok 4.75 x 11.5mm Implant 5.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS513
  	
 
  	
Micro-Lok 4.75 x 13mm Implant 5.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHPSS515
  	
 
  	
Micro-Lok 4.75 x 15mm Implant 5.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHSS408
  	
 
  	
Micro-Lok 3.75 x 8mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHSS410
  	
 
  	
Micro-Lok 3.75 x 10mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHSS412
  	
 
  	
Micro-Lok 3.75 x11.5mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHSS413
  	
 
  	
Micro-Lok 3.75 x 13mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
IHSS415
  	
 
  	
Micro-Lok 3.75 x 15mm Implant 4.0 Platform, RBT
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR5009
  	
 
  	
Internal Implant RBT, Laser-Lok 5.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR50105
  	
 
  	
Internal Implant RBT, Laser-Lok 5.0 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR5012
  	
 
  	
Internal Implant RBT, Laser-Lok 5.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR5015
  	
 
  	
Internal Implant RBT, Laser-Lok 5.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR6009
  	
 
  	
Internal Implant RBT, Laser-Lok 6.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR60105
  	
 
  	
Internal Implant RBT, Laser-Lok 6.0 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR6012
  	
 
  	
Internal Implant RBT, Laser-Lok 6.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPBR6015
  	
 
  	
Internal Implant RBT, Laser-Lok 6.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPGR4009
  	
 
  	
Internal Implant RBT, Laser-Lok 4.0 x 9mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPGR40105
  	
 
  	
Internal Implant RBT, Laser-Lok 4.0 x 
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
10.5mm, 4.5 Platform
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
LPGR4012
  	
 
  	
Internal Implant RBT, Laser-Lok 4.0 x 12mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPGR4015
  	
 
  	
Internal Implant RBT, Laser-Lok 4.0 x 15mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPYR3509
  	
 
  	
Internal Implant RBT, Laser-Lok 3.5 x 9mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPYR35105
  	
 
  	
Internal Implant RBT, Laser-Lok 3.5 x 10.5mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPYR3512
  	
 
  	
Internal Implant RBT, Laser-Lok 3.5 x 12mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LPYR3515
  	
 
  	
Internal Implant RBT, Laser-Lok 3.5 x 15mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR5007
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 7mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR5009
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 9mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR50105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 10.5mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR5012
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 12mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR5015
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 15mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR6007
  	
 
  	
Single-stage Implant RBT, Laser-Lok 6.0 x 7mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR6009
  	
 
  	
Single-stage Implant RBT, Laser-Lok 6.0 x 9mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR60105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 6.0 x 10.5mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR6012
  	
 
  	
Single-stage Implant RBT, Laser-Lok 6.0 x 12mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSBR6015
  	
 
  	
Single-stage Implant RBT, Laser-Lok 6.0 x 15mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR4007
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 7mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR4009
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 9mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR40105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 10.5mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR4012
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 12mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR4015
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 15mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR5007
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 7mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR5009
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 9mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
LSGR50105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 10.5mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR5012
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 12mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSGR5015
  	
 
  	
Single-stage Implant RBT, Laser-Lok 5.0 x 15mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR3507
  	
 
  	
Single-stage Implant RBT, Laser-Lok 3.5 x 7mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR3509
  	
 
  	
Single-stage Implant RBT, Laser-Lok 3.5 x 9mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR35105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 3.5 x 10.5mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR3512
  	
 
  	
Single-stage Implant RBT, Laser-Lok 3.5 x 12mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR3515
  	
 
  	
Single-stage Implant RBT, Laser-Lok 3.5 x 15mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR4007
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 7mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR4009
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 9mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR40105
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 10.5mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR4012
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 12mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
LSYR4015
  	
 
  	
Single-stage Implant RBT, Laser-Lok 4.0 x 15mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPH3012
  	
 
  	
One-piece Implant HA 3.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPH3015
  	
 
  	
One-piece Implant HA 3.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPH3018
  	
 
  	
One-piece Implant HA 3.0 x 18mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPR3012
  	
 
  	
One-piece Implant RBT 3.0 x 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPR3015
  	
 
  	
One-piece Implant RBT 3.0 x 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
OPR3018
  	
 
  	
One-piece Implant RBT 3.0 x 18mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB4008L
  	
 
  	
Internal 5.7 Simp Sol Abut, 4.0 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB4018L
  	
 
  	
Internal 5.7 Simp Sol Abut, 4.0 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB4028L
  	
 
  	
Internal 5.7 Simp Sol Abut, 4.0 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB5508L
  	
 
  	
Internal 5.7 Simp Sol Abut, 5.5 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB5518L
  	
 
  	
Internal 5.7 Simp Sol Abut, 5.5 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PB5528L
  	
 
  	
Internal 5.7 Simp Sol Abut, 5.5 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
PBAFS1
  	
 
  	
Internal 5.7 Abutment for Screw, 1mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBAFS15
  	
 
  	
Internal 5.7mm Angled AFS, 15 Degree
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBAFS3
  	
 
  	
Internal 5.7 Abutment for Screw, 3mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBCC
  	
 
  	
Internal 5.7 Cover Cap
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH5009
  	
 
  	
Internal Implant HA 5.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH50105
  	
 
  	
Internal Implant HA 5.0 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH5012
  	
 
  	
Internal Implant HA 5.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH5015
  	
 
  	
Internal Implant HA 5.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH6009
  	
 
  	
Internal Implant HA 6.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH60105
  	
 
  	
Internal Implant HA 6.0 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH6012
  	
 
  	
Internal Implant HA 6.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBH6015
  	
 
  	
Internal Implant HA 6.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBHA08L
  	
 
  	
Internal 5.7 Simp Sol Healing Abut, 0.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBHA18L
  	
 
  	
Internal 5.7 Simp Sol Healing Abut, 1.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBHA28L
  	
 
  	
Internal 5.7 Simp Sol Healing Abut, 2.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBNHA1
  	
 
  	
Internal 5.7 Narrow Emergence Healing Abutment, 1mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBNHA3
  	
 
  	
Internal 5.7 Narrow Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBNHA5
  	
 
  	
Internal 5.7 Narrow Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR5009
  	
 
  	
Internal Implant RBT 5.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR50105
  	
 
  	
Internal Implant RBT 5.0 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR5012
  	
 
  	
Internal Implant RBT 5.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR5015
  	
 
  	
Internal Implant RBT 5.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR6009
  	
 
  	
Internal Implant RBT 6.0 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR60105
  	
 
  	
Internal Implant RBT 6.0 x 10.5mm, 5.7
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
Platform
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
PBR6012
  	
 
  	
Internal Implant RBT 6.0 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBR6015
  	
 
  	
Internal Implant RBT 6.0 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBRHA3
  	
 
  	
Internal 5.7 Regular Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBRHA5
  	
 
  	
Internal 5.7 Regular Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PBRTA
  	
 
  	
Internal 5.7 Plastic Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG4008L
  	
 
  	
Internal 4.5 Simp Sol Abut, 4.0 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG4018L
  	
 
  	
Internal 4.5 Simp Sol Abut, 4.0 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG4028L
  	
 
  	
Internal 4.5 Simp Sol Abut, 4.0 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG5508L
  	
 
  	
Internal 4.5 Simp Sol Abut, 5.5 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG5518L
  	
 
  	
Internal 4.5 Simp Sol Abut, 5.5 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PG5528L
  	
 
  	
Internal 4.5 Simp Sol Abut, 5.5 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGAFS1
  	
 
  	
Internal 4.5 Abutment for Screw, 1mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGAFS15
  	
 
  	
Internal 4.5mm Angled AFS, 15 Degree
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGAFS25
  	
 
  	
Internal 4.5mm Angled AFS, 25 Degree
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGAFS3
  	
 
  	
Internal 4.5 Abutment for Screw, 3mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGAFS5
  	
 
  	
Internal 4.5 Abutment for Screw, 5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGCC
  	
 
  	
Internal 4.5 Cover Cap
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGH4009
  	
 
  	
Internal Implant HA 4.0 x 9mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGH40105
  	
 
  	
Internal Implant HA 4.0 x 10.5mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGH4012
  	
 
  	
Internal Implant HA 4.0 x 12mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGH4015
  	
 
  	
Internal Implant HA 4.0 x 15mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGHA08L
  	
 
  	
Internal 4.5 Simp Sol Healing Abut, 0.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGHA18L
  	
 
  	
Internal 4.5 Simp Sol Healing Abut, 1.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
PGHA28L
  	
 
  	
Internal 4.5 Simp Sol Healing Abut, 2.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGNHA1
  	
 
  	
Internal 4.5 Narrow Emergence Healing Abutment, 1mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGNHA3
  	
 
  	
Internal 4.5 Narrow Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGNHA5
  	
 
  	
Internal 4.5 Narrow Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGR4009
  	
 
  	
Internal Implant RBT 4.0 x 9mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGR40105
  	
 
  	
Internal Implant RBT 4.0 x 10.5mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGR4012
  	
 
  	
Internal Implant RBT 4.0 x 12mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGR4015
  	
 
  	
Internal Implant RBT 4.0 x 15mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGRHA3
  	
 
  	
Internal 4.5 Regular Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGRHA5
  	
 
  	
Internal 4.5 Regular Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGRTA
  	
 
  	
Internal 4.5 Plastic Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGWHA3
  	
 
  	
Internal 4.5 Wide Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PGWHA5
  	
 
  	
Internal 4.5 Wide Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY4008L
  	
 
  	
Internal 3.5 Simp Sol Abut, 4.0 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY4018L
  	
 
  	
Internal 3.5 Simp Sol Abut, 4.0 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY4028L
  	
 
  	
Internal 3.5 Simp Sol Abut, 4.0 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY5508L
  	
 
  	
Internal 3.5 Simp Sol Abut, 5.5 hgt, 0.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY5518L
  	
 
  	
Internal 3.5 Simp Sol Abut, 5.5 hgt, 1.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PY5528L
  	
 
  	
Internal 3.5 Simp Sol Abut, 5.5 hgt, 2.8 Collar, Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYAFS1
  	
 
  	
Internal 3.5 Abutment for Screw, 1mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYAFS17
  	
 
  	
Internal 3.5mm Angled AFS, 17.5 Degree
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYAFS3
  	
 
  	
Internal 3.5 Abutment for Screw, 3mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYAFS5
  	
 
  	
Internal 3.5 Abutment for Screw, 5mm Collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYCC
  	
 
  	
Internal 3.5 Cover Cap
  	
 
  	
Support
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
 
  	
 
  	
Tray
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
PYH3509
  	
 
  	
Internal Implant HA 3.5 x 9mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYH35105
  	
 
  	
Internal Implant HA 3.5 x 10.5mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYH3512
  	
 
  	
Internal Implant HA 3.5 x 12mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYH3515
  	
 
  	
Internal Implant HA 3.5 x 15mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYHA08L
  	
 
  	
Internal 3.5 Simp Sol Healing Abut, 0.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYHA18L
  	
 
  	
Internal 3.5 Simp Sol Healing Abut, 1.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYHA28L
  	
 
  	
Internal 3.5 Simp Sol Healing Abut, 2.8 Collar, Laser-Lok
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYNHA1
  	
 
  	
Internal 3.5 Narrow Emergence Healing Abutment, 1mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYNHA3
  	
 
  	
Internal 3.5 Narrow Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYNHA5
  	
 
  	
Internal 3.5 Narrow Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYR3509
  	
 
  	
Internal Implant RBT 3.5 x 9mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYR35105
  	
 
  	
Internal Implant RBT 3.5 x 10.5mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYR3512
  	
 
  	
Internal Implant RBT 3.5 x 12mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYR3515
  	
 
  	
Internal Implant RBT 3.5 x 15mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYRHA3
  	
 
  	
Internal 3.5 Regular Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYRHA5
  	
 
  	
Internal 3.5 Regular Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYRTA
  	
 
  	
Internal 3.5 Plastic Temporary Abutment
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYWHA3
  	
 
  	
Internal 3.5 Wide Emergence Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
PYWHA5
  	
 
  	
Internal 3.5 Wide Emergence Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBA40
  	
 
  	
Single-stage 5.7mm Simple Solutions Abutment, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBA55
  	
 
  	
Single-stage 5.7mm Simple Solutions Abutment, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBAP40
  	
 
  	
Single-stage 5.7mm Simple Solutions Abutment Pack, 4.0mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBAP55
  	
 
  	
Single-stage 5.7mm Simple Solutions Abutment Pack, 5.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
SBHA20
  	
 
  	
Single-stage 5.7mm Healing Abutment, 2mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBHA40
  	
 
  	
Single-stage 5.7mm Healing Abutment, 4mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBL6007
  	
 
  	
Single-stage Implant, 6.0 x 7mm, 5.7mm Platform, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBL6009
  	
 
  	
Single-stage Implant, 6.0 x 9mm, 5.7mm Platform, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBPHC40
  	
 
  	
Simple Solutions 5.7mm Healing Cap, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBPHC55
  	
 
  	
Simple Solutions 5.7mm Healing Cap, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR5007
  	
 
  	
Single-stage Implant RBT 5.0 x 7mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR5009
  	
 
  	
Single-stage Implant RBT 5.0 x 9mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR50105
  	
 
  	
Single-stage Implant RBT 5.0 x 10.5mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR5012
  	
 
  	
Single-stage Implant RBT 5.0 x 12mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR5015
  	
 
  	
Single-stage Implant RBT 5.0 x 15mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR6007
  	
 
  	
Single-stage Implant RBT 6.0 x 7mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR6009
  	
 
  	
Single-stage Implant RBT 6.0 x 9mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR60105
  	
 
  	
Single-stage Implant RBT 6.0 x 10.5mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR6012
  	
 
  	
Single-stage Implant RBT 6.0 x 12mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SBR6015
  	
 
  	
Single-stage Implant RBT 6.0 x 15mm, 5.7mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGA40
  	
 
  	
Single-stage 4.5mm Simple Solutions Abutment, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGA55
  	
 
  	
Single-stage 4.5mm Simple Solutions Abutment, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGAP40
  	
 
  	
Single-stage 4.5mm Simple Solutions Abutment Pack, 4.0mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGAP55
  	
 
  	
Single-stage 4.5mm Simple Solutions Abutment Pack, 5.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGHA20
  	
 
  	
Single-stage 4.5mm Healing Abutment, 2mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGHA40
  	
 
  	
Single-stage 4.5mm Healing Abutment, 4mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGL5007
  	
 
  	
Single-stage Implant, 5.0 x 7mm, 4.5mm Platform, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGL5009
  	
 
  	
Single-stage Implant, 5.0 x 9mm, 4.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
Platform, Laser-Lok Complete
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
SGPHC40
  	
 
  	
Simple Solutions 4.5mm Healing Cap, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGPHC55
  	
 
  	
Simple Solutions 4.5mm Healing Cap, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR4007
  	
 
  	
Single-stage Implant RBT 4.0 x 7mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR4009
  	
 
  	
Single-stage Implant RBT 4.0 x 9mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR40105
  	
 
  	
Single-stage Implant RBT 4.0 x 10.5mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR4012
  	
 
  	
Single-stage Implant RBT 4.0 x 12mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR4015
  	
 
  	
Single-stage Implant RBT 4.0 x 15mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR5007
  	
 
  	
Single-stage Implant RBT 5.0 x 7mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR5009
  	
 
  	
Single-stage Implant RBT 5.0 x 9mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR50105
  	
 
  	
Single-stage Implant RBT 5.0 x 10.5mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR5012
  	
 
  	
Single-stage Implant RBT 5.0 x 12mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SGR5015
  	
 
  	
Single-stage Implant RBT 5.0 x 15mm, 4.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SPBHA08
  	
 
  	
Internal 5.7 plat Simp Sol Healing Abut, 0.8 collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SPGHA08
  	
 
  	
Internal 4.5 plat Simp Sol Healing Abut, 0.8 collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SPGHA18
  	
 
  	
Internal 4.5 plat Simp Sol Healing Abut, 1.8 collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SPGHA28
  	
 
  	
Discontinued - Internal 4.5 plat Simp Sol Healing Abut, 2.8 collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SPYHA28
  	
 
  	
Internal 3.5 plat Simp Sol Healing Abut, 2.8 collar
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYA40
  	
 
  	
Single-stage 3.5mm Simple Solutions Abutment, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYA55
  	
 
  	
Single-stage 3.5mm Simple Solutions Abutment, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYAP40
  	
 
  	
Single-stage 3.5mm Simple Solutions Abutment Pack, 4.0mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYAP55
  	
 
  	
Single-stage 3.5mm Simple Solutions Abutment Pack, 5.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYHA20
  	
 
  	
Single-stage 3.5mm Healing Abutment, 2mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYHA40
  	
 
  	
Single-stage 3.5mm Healing Abutment, 4mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
SYPHC40
  	
 
  	
Simple Solutions 3.5mm Healing Cap, 4.0mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYPHC55
  	
 
  	
Simple Solutions 3.5mm Healing Cap, 5.5mm
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR3507
  	
 
  	
Single-stage Implant RBT 3.5 x 7mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR3509
  	
 
  	
Single-stage Implant RBT 3.5 x 9mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR35105
  	
 
  	
Single-stage Implant RBT 3.5 x 10.5mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR3512
  	
 
  	
Single-stage Implant RBT 3.5 x 12mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR3515
  	
 
  	
Single-stage Implant RBT 3.5 x 15mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR4007
  	
 
  	
Single-stage Implant RBT 4.0 x 7mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR4009
  	
 
  	
Single-stage Implant RBT 4.0 x 9mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR40105
  	
 
  	
Single-stage Implant RBT 4.0 x 10.5mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR4012
  	
 
  	
Single-stage Implant RBT 4.0 x 12mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYR4015
  	
 
  	
Single-stage Implant RBT 4.0 x 15mm, 3.5mm Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
SYTPHA30
  	
 
  	
Single-stage 3.5mm two-piece Healing Abutment, 3mm high
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TL4607
  	
 
  	
Tapered Internal Implant, 4.6 X 7.5mm, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TL4609
  	
 
  	
Tapered Internal Implant, 4.6 X 9mm, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TL5807
  	
 
  	
Tapered Internal Implant, 5.8 X 7.5mm, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TL5809
  	
 
  	
Tapered Internal Implant, 5.8 X 9mm, Laser-Lok Complete
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR3809
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 3.8 x 9mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR3810
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 3.8 x 10.5mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR3812
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 3.8 x 12mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR3815
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 3.8 x 15mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR4607
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 4.6 x 7.5mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR4609
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 4.6 x 9mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR4610
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
 
  	
 
  	
4.6 x 10.5mm, 4.5 Platform
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
TLR4612
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 4.6 x 12mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR4615
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 4.6 x 15mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR5807
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 5.8 x 7.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR5809
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 5.8 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR5810
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 5.8 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR5812
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 5.8 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLR5815
  	
 
  	
Tapered Internal Implant RBT, Laser-Lok 5.8 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX3809
  	
 
  	
Tapered Internal Implant, 3.8 x 9mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX3810
  	
 
  	
Tapered Internal Implant, 3.8 x 10.5mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX3812
  	
 
  	
Tapered Internal Implant, 3.8 x 12mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX3815
  	
 
  	
Tapered Internal Implant, 3.8 x 15mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX4607
  	
 
  	
Tapered Internal Implant, 4.6 x 7.5mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX4609
  	
 
  	
Tapered Internal Implant, 4.6 x 9mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX4610
  	
 
  	
Tapered Internal Implant, 4.6 x 10.5mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX4612
  	
 
  	
Tapered Internal Implant, 4.6 x 12mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX4615
  	
 
  	
Tapered Internal Implant, 4.6 x 15mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX5807
  	
 
  	
Tapered Internal Implant, 5.8 x 7.5mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX5809
  	
 
  	
Tapered Internal Implant, 5.8 x 9mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX5810
  	
 
  	
Tapered Internal Implant, 5.8 x 10.5mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX5812
  	
 
  	
Tapered Internal Implant, 5.8 x 12mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TLX5815
  	
 
  	
Tapered Internal Implant, 5.8 x 15mm, Mountless, RBT+Laser-Lok
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR3809
  	
 
  	
Tapered Internal Implant RBT 3.8 x 9mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR3810
  	
 
  	
Tapered Internal Implant RBT 3.8 x 10.5mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

 

 

	
Item #
  	
 
  	
Description
  	
 
  	
Package
 Type
  	
 
  	
Jan
  	
 
  	
Feb
  	
 
  	
March
  	
 
  	
April
  	
 
  	
May
  	
 
  	
Jun
  	
 
  	
Jul
  	
 
  	
Aug
  	
 
  	
Sep
  	
 
  	
Oct
  	
 
  	
Nov
  	
 
  	
Dec
  	
 
  	
Fin
 Pipe
  
	
TMR3812
  	
 
  	
Tapered Internal Implant RBT 3.8 x 12mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR3815
  	
 
  	
Tapered Internal Implant RBT 3.8 x 15mm, 3.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR4607
  	
 
  	
Tapered Internal Implant RBT 4.6 x 7.5mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR4609
  	
 
  	
Tapered Internal Implant RBT 4.6 x 9mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR4610
  	
 
  	
Tapered Internal Implant RBT 4.6 x 10.5mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR4612
  	
 
  	
Tapered Internal Implant RBT 4.6 x 12mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR4615
  	
 
  	
Tapered Internal Implant RBT 4.6 x 15mm, 4.5 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR5807
  	
 
  	
Tapered Internal Implant RBT 5.8 x 7.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR5809
  	
 
  	
Tapered Internal Implant RBT 5.8 x 9mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR5810
  	
 
  	
Tapered Internal Implant RBT 5.8 x 10.5mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR5812
  	
 
  	
Tapered Internal Implant RBT 5.8 x 12mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TMR5815
  	
 
  	
Tapered Internal Implant RBT 5.8 x 15mm, 5.7 Platform
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP3105L
  	
 
  	
Laser-Lok 3.0 Implant, 10.5mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP312L
  	
 
  	
Laser-Lok 3.0 Implant, 12mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP315L
  	
 
  	
Laser-Lok 3.0 Implant, 15mm
  	
 
  	
Blister
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP3CC
  	
 
  	
3.0mm Cover Cap
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP3HA3
  	
 
  	
3.0mm Healing Abutment, 3mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
TP3HA5
  	
 
  	
3.0mm Healing Abutment, 5mm Height
  	
 
  	
Support Tray
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
[***]
  	
 
  	
 
  

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00183-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00183-of-00352.parquet"}]]