Source: http://docplayer.net/12475672-Em-ekgo-gr-ouf-diplomat-ot39-1-company-name-5-510-k-summary-oc-submission-correspondent-emergo-group-inc-company-address.html
Timestamp: 2018-12-18 14:28:09
Document Index: 128328615

Matched Legal Cases: ['art 1', 'art.1', 'art 1', 'art 1', 'arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803', 'art 21']

EM GR.OUF DIPLOMAT. OT39?1 Company Name: (K)SUMMARY Oc. Submission Correspondent. Emergo Group, Inc. Company Address: - PDF
EM GR.OUF DIPLOMAT. OT39?1 Company Name: (K)SUMMARY Oc. Submission Correspondent. Emergo Group, Inc. Company Address:
Download "EM EkGO @ GR.OUF DIPLOMAT. OT39?1 Company Name: 5. 510(K)SUMMARY Oc. Submission Correspondent. Emergo Group, Inc. Company Address:"
1 EM GR.OUF DIPLOMAT (K)SUMMARY Oc Submission Correspondent OT39?1 Company Name: Emergo Group, Inc. Company Address: 816 Congress Avenue Suite 1400 Austin, TX Company Contact: Stuart R. Goldman Senior Consultant Phone: Fax: Submission Date: February 11, 2013 Website: Submission Sponsor Company Name: DIPLOMAT DENTAL, s.r.o. Company Address: Vrbovsk6 cesta Pie~tany Slovak Republic Country: Slovakia Phone: Fax: Website: hi rana.sk Device Classification Device Sponsor: DIPLOMAT DENTAL, s.r.o. Product Classification Name: Unit, Operative Dental Product Code: EIA Regulation Number: Classification Panel: Dental Devices Regulatory Class: Class I 5-1
2 DPLOM;AT Predicate Device Sirona C8+Dental Operative Unit (K(032543) Statement of Intended Use Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law. Device Description Diplomat dental operative units are modern, ergonomically designed, dental systems offered in a wide range of models depending on the specific end user requirements. Diplomat dental operative units are AC-powered devices that are intended to supply power to, and serve as a base for, other dental devices and accessories - such as hand-pieces, operating lights, curing lights, ultrasonic instruments, hygiene instruments, etc. - and deliver electric, air, water and vacuum power to them. Diplomat dental operative units are offered either with the patient dental chair or as a free-standing unit without the chair for those end-users with existing patient chairs that they want to use. Diplomat dental operative units are offered in the following models and with the following accessories: 5-2
3 EM RO-UF Diplomat Dental Operative Units: Adept DA 380, Adept DA 370, Adept DA 170, Adept DA 130, Adept DA 110A, Consul DC 350, Consul DC 310, Consul DC 180, Diplomat Consul DC 170, Diplomat Consul DC 170 (Orthodontic), Diplomat Lux DL 320; Diplomat Lux DL 210 Diplomat Dental Accessories: Dental Chair DE 20, Dental Chair DM 20, Dental Stools D 101, Dental Light Xenos, Dental Light Sirius Predicate Device Comparison Diplomat dental operative units by DIPLOMAT DENTAL have been shown to be Substantially Equivalent to the C8+Dental Operative Units manufactured by Sirona Dental Systems previously cleared by the FDA under K The applicant and predicate devices are very similar in overall design and technology; principle of operation, intended use, materials, construction, and available accessories offered for them. The differences between the applicant and predicate devices do not raise any new questions of safety or effectiveness. Some select properties and characteristics of the applicant and predicate devices are compared side-by-side in the table below. 510(k) Pending K Models Adept Models: DA 380, DA 370, DA Multiple versions Similar 170, CA 130, DA 110; Consul Models: DC 350, DC 310, DC 180, DC 170 and DC orthodontic; and Lux Models: DL 320, and DL 210 Product Code FIA EIA Same Regulation Same Number Regulation Unit, Operative, Dental Unit, Operative, Dental Same Name Place of Use Dental clinic Dental clinic Same Intended Dentists; assistants and hygienists Dentists; assistants and hygienists Same Iusers I I 110v/(230 VAC) 110Ov/11Sv/127v/(230 VAC) Similar Power Supply 50/60 Hz 50/60 Hz utility Supply Compressed air and water Compressed air and water Same 5-3
4 DIPLOMAT Protection Class 1 equipment Class 1 equipment Same Class Degree of Type B of applied parts Type B of applied parts Same Protection Professionally installed; available Professionally installed; not available Same Installation with chair and cart mounted with chair and cart mounted options. options. Air Pressure 450 kpa/800 kpa (min/max.) 550 kpa/750 kpa (min/max.) Similar 5-4 Water 300 kpa/600 kpa (mm/.max.) 250 kpa/600 kpa (min./max.) Similar Pressure Electrical IEC IEC Same Safety EMVC EN IEC Similar Performance ISO Diplomat dental operative units The C8 + Dental Operative Unit with Similar are self-contained dental accessories are intended to supply treatment units that contain power to and serve as a base for dental vacuum system and water supply devices and accessories. This product and separate compressor placed includes a dental chair. The unit is Statement of Intended Use outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered by with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants, The C8 + Dental Operative Unit is offered wilt the optional Sivision 3, an intraoral camera system intended to provide the dentist and patient with intraoral videa images to view the condition of the teeth and oral cavity.
5 DIPLOMAT of a licensed dentist or a hygienist if permitted by applicable law. I I Non-Clinical Data - Device Bench Testing As part of demonstrating the safety and effectiveness of its line of Diplomat dental operative units, DIPLOMAT DENTAL has submitted these devices for performance testing in accordance with the applicable sections of the following international standards and FDA guidance documents: * IEC :2005, Medical electrical equipment - Part 1, General requirements for basic safety and essential performance * EN :2007, Medical electrical equipment - Part.1-2, General r~quirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests * EN :2009, Medical electrical equipment - Part 1, General requirements for basic safety and essential performance * ISO :2004, Dentistry - Dental Units - Part 1: General requirements and test methods Clinical Data Not applicable to this 510(k) submission. Substantially Equivalence By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and 5-5
6 EM, E kgo GR:OUP DIPLOMAT that the new device does not raise new questions regarding its safety and effectiveness when compared to the predicate device. It has been shown in this 510(k) submission that the differences between the Diplomat dental operative units by DIPLOMAT DENTAL when compared to the Sirona Dental Systems C8+Dental Operative Units (K032543) are minimal and do not raise any questions regarding their safety and effectiveness. Diplomat dental operative units, as designed and manufactured are therefore determined to be substantially equivalent to the predicate device. 5-6
7 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service t Food and Drug Administraton October 30, 2013 Diplomat Dental, S.R.O. C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 81i6 Congress Avenue, Suite 1400 Austin, TX Re: K Trade/Device Name: Dental Operative Unit Regulation Number: 21 CER Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 23, 2013 Received: September 24, 2013 Dear Mr. Goldman: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRI- does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
8 Page 2 - Mr. Goldman Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CER Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfr-ee number (800) or (301) or at its Internet address htt:// Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to httn:// for the CDRI-'s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) or (301) or at its Internet address http):// Sincerely yours, Enclosure Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Devices Evaluation Center for Devices and Radiological Health
9 INDICATIONS FOR USE 510(K) NUMBER (IF KNOWN): K Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are Intended for use to provide general dental restorative care and hygiene procedures In both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist If permitted by applicable law. Prescription Use X Over-The-Counter Use- (Part 21 CFR 801 Subpart D) AN/R(21 CFR 801 Subpart CQ (PLEASE 00 NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concuence of CDRH, Office of Device Evaluation (ODE) AndrewL ;k-04'001