WARNING LETTER
Reset Technology Corporation
MARCS-CMS 704828 —
June 09, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mark Teufel
Recipient Title
Acting CEO
Reset Technology Corporation
4200 West Royal Lane, Suite # 125
Irving
,
TX
75063
United States
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 704828
June 9, 2025
Dear Mark Teufel:
During an inspection of your firm located in Englewood Cliffs, NJ, from October 29, 2024, through December 20, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ResetSmile Partial Denture Device and the at-home ResetSmile Impression Kit Device. The ResetSmile Partial Denture Device is a removeable dental appliance used to replace missing teeth and the ResetSmile Impression Kit Device is an impression kit used to help make the removeable dental appliance. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Quality System Regulation Violation(s)
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Mr. Justin S. Marks, VP Clinical Operations/Quality Representative, in an email dated January 13, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
Specifically, you failed to define and document procedures for process validation. For example, you have no objective evidence that the following manufacturing and cleaning processes for your ResetSmile Partial Denture Devices, for which specifications such as anatomical features, mechanical strength, or residue removal cannot be verified without
(b)(4)
testing, consistently produce a result or product that meets predetermined specifications with a high degree of assurance:
a.
Scanning and CAD Design
i. You utilize the
(b)(4)
Dental Scanner to generate an initial 3D scan of the model cast from the impression taken by the customer with your at-home ResetSmile Impression Kit Device but have no documented validation to support your intended use of this software application.
ii. You utilize the
(b)(4)
to develop the patient-matched CAD design from the above 3D scan of the model cast but have no documented validation to support your intended use of this software application.
b.
3-Dimensional (3D) Printing
i. You utilize
(b)(4)
3D Printers with the
(b)(4)
software to 3D print your ResetSmile Partial Denture Device based on the above CAD design but have no documented validations which establish the process parameter settings (e.g., filament diameter, fill density, extruder temperature, bed temperature, print speed, layer thickness, etc.) under which your 3D printers are able to consistently meet predefined specifications alongside your intended use of the
(b)(4)
software application.
ii. You utilize the
(b)(4)
3D Printer;
(b)(4)
3D Printers; or
(b)(4)
3D Printers to 3D print the mold to trial fit your ResetSmile Partial Denture Device but have no documented validations which establish the process parameters (e.g., filament diameter, fill density, extruder temperature, bed temperature, print speed, layer thickness, etc.) under which your 3D printers are able to consistently meet predefined specifications.
c.
Post-printing Quality Control (QC) Validation (i.e., Test Method)
i. You utilize the
(b)(4)
software, as a part of finished device acceptance, to identify conforming and nonconforming areas for your finished device through comparison of the overlay of the 3D scan of your ResetSmile Partial Denture Device (
(b)(4)
) with the initial 3D scan (via
(b)(4)
Dental Scanner software) of the model cast from the impression taken by the customer with your at-home ResetSmile Impression Kit Device but have no documented validation to support your intended use of this software application.
d.
Cleaning
i. You utilize the
(b)(4)
to remove manufacturing material (e.g.,
(b)(4)
) applied to your ResetSmile Partial Denture Device prior to the Post-printing QC Validation above but have no documented validation that establishes the process parameter settings (e.g., clean time, water quality, degassing time, bath cycle, etc.) under which your
(b)(4)
is able to consistently meet predefined specifications for cleanliness.
ii. You utilize the
(b)(4)
to
(b)(4)
clean your ResetSmile Partial Denture Device after
(b)(4)
but have no documented validation that this
(b)(4)
cleaner is able to consistently meet predefined specifications for cleanliness.
We reviewed your firm's response and conclude that it is not adequate. You state process validations are not required as they have already been performed as part of the regulatory process for the FDA cleared materials used in your devices. You also state that you use FDA listed 3D scanners and computer assisted design and manufacturing (CAD/CAM) software to manufacture each patient specific device (which has been validated by the manufacturer as part of their regulatory process) and that internal validation and verification of the patient specific device is performed as part of the QC Validation Process to ensure that the partial denture fits the patient model since each product has different patient specifications. As such, no corrective actions were identified. However, it is unclear how you are able to ensure (1) that predetermined specifications are consistently met with a high degree of assurance during the scanning, 3D printing, and post-printing quality control process steps described above for your ResetSmile Partial Denture Devices without validation of the software workflow for its intended use according to an established protocol with predefined acceptance criteria and (2) quality for all devices built in a
(b)(4)
cycle,
(b)(4)
cycles, and
(b)(4)
machines, where the results of a process (output specifications) cannot be fully verified by subsequent inspection and test. In addition, you did not provide a response on how you plan to address the lack of cleaning validations for your
(b)(4)
and
(b)(4)
cleaning processes to ensure that manufacturing material is able to be consistently removed, with a high degree of assurance, from your devices which present challenges for residue removal due to the complex geometry prevalent with such devices (e.g.,
(b)(4)
with limited or no access, etc.). Therefore, please provide a response on how you plan to address the above deficiencies.
2. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a).
Specifically, the "Control of Nonconformity Process" procedure (8300-01; Rev.0; Effective: 10/25/24) and "Non-Confirming Material Report" form (8300-01-01; Rev.0; Effective: 10/25/24), which were implemented after the preannouncement of the FDA inspection on 10/24/24, are inadequate in that there are no requirements to document:
 Nonconformances in sufficient detail to describe what failed to meet specification(s);
 Evaluations of nonconformances to determine the need for investigations; and
 Dispositions of nonconformances.
For example, there were no descriptions, evaluations for the need for investigations, and dispositions documented for
(b)(4)
cases of nonconforming product identified on the "Internal Remakes log" from 2/2/22 to 10/28/24 under three general categories: "Failed print" (
(b)(4)
cases); "Fabrication error" (
(b)(4)
cases); and "Failed QC" (
(b)(4)
cases).
We reviewed your firm's response and concluded that it is not adequate. You plan to create a new procedure to include the definition of a nonconformance, visual identification of nonconforming product, and disposition instructions; develop a new disposition log; perform a statistical analysis of the rework cases to determine if additional corrective actions are needed; and schedule training on updated procedures under corrective action report # CA011 around January 31, 2025. However, you have not identified any corrective actions to ensure that (1) your procedures and forms require that nonconformances are recorded in sufficient detail to include what failed to meet specification(s) to allow determination of potential causes and evaluations of nonconformances to determine the need for investigations and (2) retrospective review of nonconformances, for a reasonable period of time, to document what failed to meet specifications, conduct evaluations to determine the need for investigations, and record dispositions. In addition, please provide an update on the progress of your identified corrective actions, including any supporting evidence of completion for review, timelines for completion, and plan for how you will address the inadequacies pointed out in your response.
3. Failure to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications and documentation of rework and reevaluation activities, including determination of any adverse effect from the rework upon the product, in the device history record (DHR), as required by 21 CFR 820.90(b)(2).
Specifically, you failed to define and document procedures for rework which include requirements to retest and reevaluate reworked devices and document the rework and reevaluation, including adverse impact assessments on reworked devices, in the DHR. Per your VP of Clinical Operations and head Dental Technician, approximately
(b)(4)
of manufactured ResetSmile Partial Denture Devices undergo final adjustment (rework) during the Final Quality Control (QC) step of the "Quality Control Validation Process" (7506-01; Rev. 0; Effective: 2/19/24) which states that upon completion of the scan of the finished device, where
(b)(4)
areas indicate the need for readjustment, "
***the finished device is brought to the quality control technician for final QC analysis, including possible adjustments, and cleaning***
." All eleven (11) scans of the ResetSmile Partial Denture Devices reviewed (lot #: 20022199; 20023601; 20023705; 20024773; 20025934; 20026261; 20026272; 20026352; 20021720; 20018940; 20021572) revealed that these initial scans evaluated during the final QC step contained
(b)(4)
areas which required adjustment. However, none of the readjustments for these devices were treated as reworks which would require additional rescans and retention of the scans to confirm specifications are met before release and documented assessment of any adverse effects.
We reviewed your firm's response and concluded that it is not adequate. You state the QC Validation Process (7506-01) is designed to identify and adjust potentially ill-fitting partial dentures prior to delivery to the dentist and consumer which surpasses requirements of the regulation and is in contrast to relying on the prescribing dentist to perform their own post-delivery adjustments, which is a universally accepted method. As such, no corrective actions were identified. However, your firm is not meeting the requirements of 21 CFR 820.90(b)(2) with regards to the handling of adjustments (reworks). Therefore, please provide a response on how you plan to address the above deficiencies.
4. Failure to adequately investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).
Specifically, you failed to investigate or adequately investigate complaints alleged to not meet specifications, as noted in the following examples:
i.
Complaint # 22952 (lot # 20021720) dated 6/26/24
: "
***The device is really thick and I cannot get it in with out [sic] significant pain, and once it is in, I cannot close my mouth, as the new device doesn't allow room for my bottom teeth. It also sticks out forward and leaves a "v" shaped gap at the bottom between the device and my natural tooth***
."
You responded to customer by sending an adjustment kit to the patient. However, there was no documented investigation into what may have caused or contributed to the device thickness.
ii.
Complaint # 55465 (lot # 20027016) dated 10/16/24
: "
***The partials don't t [sic] fit properly and made my gums hurt and bleed. My front teeth hurt, feels like my teeth [as] being pushed forward. Both my upper and lower don't fit properly***
."
You requested photos and information on experienced issues from the customer and sent another impression kit to the patient for a remake. However, there was no documented investigation into what may have caused or contributed to the device fit issues.
We reviewed your firm's response and conclude that it is not adequate. Your firm plans to assess all open complaints at regular intervals to determine the effectiveness of the complaint handling process, need for CAPA, and MDR under corrective action report # CA013 around January 31, 2025. However, there were no corrective actions identified to retrospectively review and evaluate complaints, for a reasonable period of time, to determine (1) the need for an investigation (including justification when an investigation was not needed) and (2) definitively investigate any complaints which allege failures of your device, labeling, or packaging to meet any of its specifications. Please provide an update on the progress of your identified corrective actions, including any supporting evidence of completion for review, timelines for completion, and plan for how you will address the inadequacies pointed out in your response.
5. Failure to adequately maintain complaint files and adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, including evaluation of complaints to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a).
Specifically, your "Complaint Handling Process" procedure (8202-01; Rev.0; Effective: 6/22/22) is inadequate in that it fails to:
a. Outline the criteria for when your follow-up questionnaire should be sent to complainants. For example, you emailed customers questionnaires (uncontrolled), which listed questions such as “
***Can you feel any roughness or sharp edges on the device that are contributing to sore spots in your mouth?***
” or “
***Does the device feel like it is placing too much pressure on the gums? In any specific area or overall tightness?***
” to attempt to obtain details on customer experienced issues for Complaints # 21161 (lot # 20026782) and # 56207 (lot # 20027010) but not for the following complaints:
i.
Complaint # 22952 (lot # 20021720) dated 06/26/2024
: “
***The device is really thick and I cannot get it in with out [sic] significant pain, and once it is in, I cannot close my mouth, as the new device doesn't allow room for my bottom teeth. It also sticks out forward and leaves a "v" shaped gap at the bottom between the device and my natural tooth***
.”
ii.
Complaint # 55465 (lot # 20027016) dated 10/16/2024
: “
***The partials don’t t [sic] fit properly and made my gums hurt and bleed. My front teeth hurt, feels like my teeth [as] being pushed forward. Both my upper and lower don’t fit properly***
.”
b. Ensure that complaints include evaluations of whether they represent events which require reporting to the FDA under 21 CFR 803 (Medical Device Reporting) based on sufficient information obtained from customers to determine whether the complaints meet the definition of MDR reportable events. For example, your VP of Clinical Operations acknowledged that none of your complaint records included documented evaluations on whether the complaints were reportable, including Complaints # 22952 and # 55465 above as well as the following:
i.
Complaint # 21161 (lot # 20026782) dated 10/14/24
: “
***The bottom is so tight, I have damaged the inside of my mouth after just one attempt. I tried again but my mouth was to [sic] sore.” The patient also stated that the device was “painful to clip in, cut me in the front of my lower teethbottom [sic]”. Your firm responded by sending an impression kit to the patient for a remake***
.”
ii.
Complaint # 56207 (lot # 20027010) dated 10/23/24
: “
***the bottom teeth are coming on contact with the partial causing it to move. This friction is very painful and has caused blistering… The pain that I feel goes from pressure to scratching to stabbing***
.”
We reviewed your firm's response and conclude that it is not adequate. You plan to add the definition of a complaint to your MDR and complaint procedures; include a section for MDR evaluations to the complaint form; assess all open complaints at regular intervals to determine the effectiveness of the complaint handling process, need for CAPA, and MDR; and provide training on the revised processes under corrective action report # CA013 around January 31, 2025. In addition, you reported that none of the 1,840 complaints as of 11/21/24 were MDR reportable. However, there were no corrective actions identified to ensure uniformity of the complaint process by establishing criteria for when complainants are sent questionnaires and ensure that sufficient information is requested from customers to determine whether complaint events meet the definition of MDR reportability under 21 CFR 820.3(o). Please provide an update on the progress of your identified corrective actions, including any supporting evidence of completion for review, timelines for completion, and plan for how you will address the inadequacies pointed out in your response.
6. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, your "Corrective & Preventive Action (CAPA) Process" (8502-01; Rev. 0; 6/22/22) and "Quality Objectives Management" (5401-01; Rev. 0; 10/7/24) procedures are inadequate in that:
a. 8502-01 (nor any other procedure) does not require internal remakes of your ResetSmile Partial Denture Devices, arising from issues during manufacturing, as inputs into the CAPA process to identify existing and potential causes of nonconforming product or other quality problems, as required by 21 CFR 820.100(a)(1). For example, you remade 64 devices during the month of October 2024 due to issues categorized as failed 3D printing, fabrication errors, and failed quality control but none of this data was analyzed to identify existing and potential causes of nonconforming product or other quality problems.
b. Neither 8502-01 nor 5401-01 require appropriate statistical methodology to detect recurring quality problems, as required by 21 CFR 820.100(a)(1). For example, you only evaluate complaint data by determining whether the
(b)(4)
percentage of rework (defined as the sum of adjustments kits, remakes, and refunds sent to customers divided by the number of customer orders received for the
(b)(4)
) exceeds
(b)(4)
%. However, the
(b)(4)
percentage of rework calculation includes non-quality data such as refunds and lots which are different that the lots ordered for the
(b)(4)
. Therefore, you do not employ appropriate statistical methodology to any of your complaints, loosely categorized as "issue with fit in mouth;" "design preference;" "incorrect bite/occlusion;" "fabrication error;" "product not aesthetically pleasing;" "issue with fit on model;" "unknown;" and "wrong tooth shade," to detect recurring quality problems.
c. 8502-01 does not require verification or validation of the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, you did not verify or validate that the corrective action identified under CAPA # 002 (corrected date of 11/6/23) to use adjustment kits, to address the observed increase in adjustments and remake rates from fit issues, were effective and did not adversely affect your ResetSmile Partial Denture Devices prior to sending them to customers.
We reviewed your firm's response and conclude that it is not adequate. You clarify that the quality data analysis is performed as part of the "Quality Objectives Management" (5401-01 Rev. 0) and "Management Review" (5600-M1 Rev. 0) processes and that there were no trends noted between May to October 2024 for the three (3) weeks where the value for percentage for rework was above
(b)(4)
. As such, no corrective actions were identified. Therefore, please provide a response on how you plan to address the above deficiencies.
7. Failure to establish and maintain procedures to adequately control environmental conditions, which could reasonably be expected to have an adverse effect on product quality and periodically inspect the environmental control system to verify that the system, including necessary equipment, is adequate and functioning properly, as required by 21 CFR 820.70(c).
Specifically:
a. You failed to define and document procedures to control environmental conditions for your production area consisting of
(b)(4)
3D Printers, used to manufacture your ResetSmile Partial Denture Devices. For example:
i. On 11/6/24, the investigator observed out of specification temperatures of 92.3℉ (33.50℃) and 92.4℉ (33.56℃) on two separate temperature and humidity monitors, which were above the "Environment Requirements" of
(b)(4)
℃ specified in the "
(b)(4)
3D Printer User Guide." In addition, the humidity value for one of the monitors was below the requirement of
(b)(4)
in this same guide. These out of specification values affected
(b)(4)
production lots that were being printed across
(b)(4)
different
(b)(4)
3D Printers at the time.
ii. On 11/19/24, the investigator also observed an out of specification temperature of 95.1℉ (35.06℃) and 14.4% humidity on one temperature and humidity monitor, which were outside the temperature (
(b)(4)
℃) and humidity (
(b)(4)
) ranges specified in the "
(b)(4)
3D Printer User Guide." This out of specification temperature and humidity affected
(b)(4)
production lots that were being printed across
(b)(4)
different
(b)(4)
3D Printers at the time.
Moreover, you do not regularly log the temperature and humidity values or regulate the temperature in the production area.
b. You failed to periodically inspect your temperature and humidity monitors to ensure that they are suitable for their intended use and calibrated or evaluated for accuracy.
We reviewed your firm's response and conclude that the adequacy cannot be determined at this time. You plan to calibrate your temperature and humidity sensor; set up alerts when values exceed specified requirements; control ambient humidity and temperature of the room; and develop an "Environmental Requirements" procedure under corrective action report # CA012 around January 31, 2025. Please provide updates on the progress of these corrective actions and corrections, including # CA012, and any supporting evidence.
8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g).
Specifically, you failed to meet specified placement requirements for your
(b)(4)
3D Printers, which are used to manufacture your ResetSmile Partial Denture Devices. For example, on 11/19/24, the investigator observed that the distance between the sides of 3D printers
(b)(4)
and
(b)(4)
and
(b)(4)
and
(b)(4)
was approximately 8 cm and the distances between the corresponding
(b)(4)
and backs of 3D printers
(b)(4)
and
(b)(4)
were approximately 5.5 cm and 6 cm, respectively, which are all below the specified placement requirements noted in the "
(b)(4)
3D Printer User Guide" which requires that "
***the distances of the left, right and back [sic] side space should be at least 20cm***
."
We reviewed your firm's response and conclude that the adequacy cannot be determined at this time. You plan to rearrange the printers and printer racks to accommodate the recommended spacing guidelines in the manufacturer's instructions for use; reposition the
(b)(4)
; and document these parameters in "Environmental Requirements" under corrective action report # CA012 around January 31, 2025. Please provide updates on the progress of these corrective actions and corrections, including # CA012, and any supporting evidence.
9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, including documentation of training, as required by 21 CFR 820.25(b).
Specifically, you failed to implement your "New Hire/Training of Personnel Process" (SOP 6202-01; Rev. 0; Effective: 6/17/24) which requires both acknowledgment of training on the "Training Acknowledgment Form" (6202-01-04; Rev. 0; Effective: none) and identification of training needs by the senior manager on the "Training Needs Assessment" form (6202-01-03). For example, there were no training forms completed for the following procedures:
 "Control of Nonconformity Process" (SOP 8300-01; Rev. 0; Effective: 10/25/24)
 "Complaint Handling Process" (SOP 8202-01; Rev. 0; Effective: 06/22/22)
 "Internal Rework Process" (SOP 8304-01; Rev. 0, Effective: 6/22/24)
 "External Rework Process" (SOP 8304-02; Rev. 0, Effective: 6/22/24)
In addition, there was no documented training on the 6201-01-04 form from before 10/28/24, which is between the dates of preannouncement (10/24/24) and the start of the inspection (10/29/24) for procedures such as (but not limited to) "QC Validation" (7506-01), "Device Fabrication" (7501-01), and "Calibration Process" (7600-01). This applies to
(b)(4)
employees, including your VP of Clinical Operations;
(b)(4)
Customer Service Representatives;
(b)(4)
CAD Technician;
(b)(4)
3D Printing Technicians;
(b)(4)
Dental Technicians;
(b)(4)
Dental Lab Technicians; and
(b)(4)
Shipping/Receiving personnel.
We reviewed your firm's response and conclude that the adequacy cannot be determined at this time. You plan to conduct a review in which 6202-01-03 will be completed for all employees and additional training will be scheduled for all affected personnel for procedures noted, including completion of the 6202-01-04 form under corrective action report # CA014 around January 31, 2025. Please provide updates on the progress of these corrective actions and corrections, including # CA014, and any supporting evidence.
Corrections and Removals Violation(s)
Our inspection also revealed that your ResetSmile Partial Denture Devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.
Significant violations include, but are not limited to, the following:
Failure to submit any report required within 10 working days of initiating a correction or removal, initiated to reduce a risk to health posed by the device or remedy a violation which may present a risk to health, as required by 21 CFR 806.10.
Your firm initiated a medical device correction by providing “adjustment kits” as a corrective measure, allowing customers to modify their ResetSmile Partial Denture Devices at home. This correction was initiated to remedy dentures that do not perform as intended, i.e., cause irritation or do not fit the patient. The adjustment kit is comprised of four items: a pink emery board, a blue emery board, a sanding stick, and a transfer stick to highlight problem areas. Your firm is instructing customers to use this kit to adjust the dentures that cause gum irritation or do not fit well. CDRH determined that the gum irritation being caused by the ResetSmile Partial Denture Devices may cause temporary or medically reversible adverse health consequences. Also, in some cases, there is a reasonable probability that ill-fitting dentures will cause serious adverse health consequences. Your firm’s actions thus meet the definition of a medical device correction or removal initiated to reduce a risk to health or remedy a violation which may present a risk to health. Therefore, this action is a medical device correction for which your firm is required to submit a Report of Correction or Removal to FDA.
Unapproved Device Violation(s)
Our inspection also revealed that your ResetSmile Partial Denture and the at-home ResetSmile Impression Kit Devices, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
For your ResetSmile Partial Denture Devices, the inspection determined that you use
(b)(4)
manufacturing to produce ResetSmile Partial Denture Devices, comprised of a resin denture base material and preformed plastic denture teeth. The
(b)(4)
manufacturing process includes the following specific steps: customers take at-home impressions using your firm’s impression kit; a dentist virtually reviews the scans of these at-home impressions; your firm uses the resin denture base material to make the denture bases with a 3D printer; your firm chemically bonds the preformed plastic teeth to the denture bases to fabricate the dentures; and your firm ships approximately
(b)(4)
percent of these dentures directly to customers.
We note that (1) partial denture devices and resin denture base material are class II devices classified under 21 CFR 872.3760 and require 510(k) clearance and (2) preformed plastic teeth are class II devices classified under 21 CFR 872.3590 and generally do not require 510(k) clearance. In your response, you do not identify a 510(k) clearance for your partial denture devices. Rather, your response seems to suggest that clearance for your partial denture devices is not required because your firm uses only cleared and 510(k) exempt materials in its manufacturing process and that the resin denture base material has a clearance. However, your firm did not provide a 510(k) number for the resin denture base material intended for use in a 3D printer—rather, your firm only provided a 510(k) number for preformed plastic teeth (K060507). Therefore, premarket notification or premarket approval is required for your ResetSmile Partial Denture Devices.
Your response did not address your at-home ResetSmile Impression Kit Devices, which the inspection revealed are shipped from your headquarters facility, located in Irving TX, directly to customers for them to use without the supervision of a dentist or other practitioner to take their own impressions for the partial dentures. Specifically, your firm’s impression kits include impression material, a retractor, a tray, and instructions which explain to customers how to take their own impressions.
Impression material is a class II device classified under 21 CFR 872.3660 and required to have 510(k) clearance, whereas retractors and trays are class I devices and generally 510(k) exempt. Your firm claims that it has a clearance for its impression material (K221668). The 510(k) summary for K221668 states that it is “intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient’s teeth and gums,” and is for prescription use only. Your impression material is intended to be used by customers to take their own impression without the supervision of a dentist, and thus does not fall within this cleared indication for use. This change to the device could significantly affect the safety and effectiveness of the impression material because customers who use at-home impression kits to take their own impressions may be more likely to take improper impressions—and improper impressions can lead to improper fabrication of the denture, which can cause bone loss/resorption, irritation, sores, and TMJ dysfunction. Moreover, it is unclear whether your firm is sending the impression material to customers with a prescription from a dentist—and the labeling of the impression kit does not appear to state that it is for prescription use only. Changing a device for prescription use only to a device for over the counter use also could significantly affect the safety or effectiveness of the device.
1
Therefore, premarket notification or premarket approval is required for your at-home ResetSmile Impression Kit Devices.
Unique Device Identification Violation(s)
The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the ResetSmile devices do not bear such a UDI.
Specifically, the labels for your ResetSmile Partial Denture and ResetSmile Impression Kit Devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of both of your ResetSmile devices (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses
(b)(4)
technology on the label of both of your ResetSmile devices (see 21 CFR 801.40(a)(2)).
In addition, your ResetSmile Partial Denture and ResetSmile Impression Kit Devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Reset Technology Corporation is therefore a “labeler” within the meaning of 21 CFR 830.3, and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.
The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).
Registration and Listing Violation(s)
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year.
Your response states that you are exempt from registration and listing under 21 CFR 807.65(i) because you are a dental laboratory. Your response explains that your firm “manufactures patient specific restorative devices (removable partial dentures) based upon a prescription from a licensed dentist” and “use[s] FDA cleared materials . . . to manufacture each patient specific device and do[es] not commercially distribute these devices.” Your response further explains that you previously registered as a medical device manufacturer for preformed plastic denture teeth based on incorrect information from a regulatory consultant and have since deactivated your registration with the FDA for fiscal year 2025.
21 CFR 807.65(i), among other things, exempts from registration and listing “[p]ersons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (i.e., patient, physician, layman, etc.) with a device or the benefits to be derived from the use of the device; for example, a…dental laboratory…whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.” Here, your firm is not providing a service through the use of previously manufactured devices. Rather, as discussed above, your firm manufactures and distributes partial denture devices using devices that lack required approval/clearance and manufactures and distributes impression kits comprised of devices that lack required approval/clearance.
As of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2025 for your facility located in Englewood Cliffs, NJ. 21 CFR 807.22(b). Therefore, your firm’s devices at your facility located in Englewood Cliffs, NJ, are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
Your firm should take prompt action to correct the violations addressed in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
We also request your attendance at a virtual Regulatory Meeting to discuss the status of the specific steps you have taken since the inspection to correct the noted violations. This meeting will also give you an opportunity to ask any questions you may have and to provide FDA additional information regarding implementation of corrective actions. Please contact Gina Brackett, Establishment Assessment Team (EAT) 1, Assistant Director, by email at gina.brackett@fda.hhs.gov within 5 business days to set up a date and time for the meeting.
Your firm’s response to the Warning Letter should be addressed to Gina Brackett, Establishment Assessment Team (EAT) 1, Assistant Director, and sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 704828” when replying. If you have any questions about the contents of this letter, please contact: Sargum C. Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Sincerely,
/S/
Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC: Justin S. Marks, VP Clinical Operations, justin@resetsmile.com
_____________________________
1
See
Deciding When to Submit a 510(k) for a Change to an Existing Device – Guidance for Industry and Food and Drug Administration Staff (Oct. 2017) (“FDA has found that the directions for use necessary for health care professionals to use a device safely and effectively can be significantly different from the directions for use necessary for lay users to use that same device safely and effectively. Therefore, changing a device labeled for prescription use only to a device that is labeled for OTC use typically could significantly affect the safety or effectiveness and would likely require submission of a new 510(k).”).
Content current as of:
06/17/2025
Regulated Product(s)
Medical Devices