(83 days)
The DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.
This document is a 510(k) Premarket Notification from the FDA for a dental guard, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present.
The document discusses the substantial equivalence of the DenTek™ Fresh Protect™ Dental Guard to a predicate device based on non-clinical performance data and biocompatibility tests.
Here is a summary of the non-clinical performance data presented for the DenTek™ Fresh Protect™ Dental Guard:
Acceptance Criteria and Device Performance (Non-Clinical)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Separation Test: Ability to keep teeth separated when jaw is clenched. | Demonstrated the finished guard's ability to keep teeth separated when the jaw is clenched. |
| Fit Test: Ability to accommodate a range of arch widths without heating or adjustments. | Demonstrated the finished guard's ability to accommodate a range of arch widths without heating or adjustments. |
| Wear Test: Durability for the intended use duration of 1-3 days. | Demonstrated the finished guard's durability for the intended use duration of 1-3 days. |
| Biocompatibility - In Vitro Cytotoxicity Assay (ISO 10993-5): Not cytotoxic. | Demonstrated as not cytotoxic. |
| Biocompatibility - Guinea Pig Maximization Test (Sensitization) (ISO 10093-10): Not a contact skin sensitizer. | Demonstrated as not a contact skin sensitizer. |
| Biocompatibility - Oral Mucosa Irritation Test (ISO 10993-10): Not irritating to the buccal mucosa. | Demonstrated as not irritating to the buccal mucosa. |
Regarding the other requested points (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training set GT):
- Sample sized used for the test set and the data provenance: Not explicitly stated as this is a non-clinical bench testing and biocompatibility assessment, not a clinical study with a patient test set. The tests involved "finished guards" or specific materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for bench tests would be the measured physical properties or biochemical reactions. For biocompatibility, established ISO standards define the endpoints.
- Adjudication method for the test set: Not applicable for non-clinical bench testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
- The type of ground truth used: For the non-clinical tests, the ground truth is derived from the established physical and chemical measurements as per the referenced ISO standards and simulation studies.
- The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided document is a 510(k) premarket notification for a physical medical device (dental guard) and thus does not contain the information relevant to an AI/ML device's acceptance criteria, study design, or ground truth establishment.
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December 22, 2020
Vincent Argiro Director, Regulatory Affairs Medtech Products, Inc. 660 White Plains Rd. Tarrytown, New York 10591
Re: K202974
Trade/Device Name: DenTek Fresh Protect Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: September 29, 2020 Received: September 30, 2020
Dear Vincent Argiro:
We have reviewed your Section 510(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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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: CDRH 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.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adiodha. M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202974
Device Name DenTek™ Fresh Protect™ Dental Guard
Indications for Use (Describe)
The DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
DenTek™ Fresh Protect™ Dental Guard
K202974 K #
1. Submitter
| Name & Address: | Medtech Products Inc.660 White Plains RoadTarrytown, NY, 10591 |
|---|---|
| Contact: | Vincent Argiro, RAC |
| Title: | Director, Regulatory Affairs |
| Phone number: | (914) 524-8721 |
| Email: | vargiro@prestigebrands.com |
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- Date Prepared December 21, 2020
3. Device Identification
| Trade/Proprietary Name: | DenTek™ Fresh Protect™ Dental Guard |
|---|---|
| Common/Usual Name: | Over-the-Counter Dental Guard |
| Classification Name: | Mouthguard, Over-the Counter |
| Regulation Number: | N/A |
| Product Code: | OBR |
| Device Class: | Unclassified |
| Classification Panel: | Division of Anesthesiology, General Surgery, Infection Control and Dental Devices |
4. Legally Marketed Predicate Device(s)
| Predicate Device: | DenTek™ Ready-Fit™ Disposable Dental Guard (K151149), Product Code |
|---|---|
| OBR |
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5. Device Description
The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.
6. Intended Use
The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device that is intended to be used by lay people for protection against the effects of nighttime teeth grinding.
The DenTek™ Fresh Protect™ Dental Guard bears the following indications for use statement:
The DenTek™ Fresh Protect™ Dental Guard is indicated for protection aqainst bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
The DenTek™ Fresh Protect™ Dental Guard intended use statement is identical to that of the predicate device.
7. Substantial Equivalence Discussion
The following table compares the DenTek™ Fresh Protect™ Dental Guard to the chosen predicate device with respect to intended use and technological characteristics. This comparison of the devices provides detailed information demonstrating the basis for the determination of substantial equivalence. Any minor differences are discussed in the narrative below the table.
| Proposed Device | Predicate Device | Differences | |
|---|---|---|---|
| Trade Name /Device Name | DenTek™ FreshProtect™ DentalGuard | DenTek™ Ready-Fit™ Dental Guard | N/A |
| 510(k) Number | TBD | K151149 | N/A |
| Date Cleared | 90 days from dateof receipt by FDA | 09/30/2015 | N/A |
| Original applicant | Medtech ProductsInc. | DenTek Oral Care,Inc. | N/A |
| REGULATORY CLASSIFICATION | |||
| Regulatory Class | Unclassified | Unclassified | None |
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| Name of GenericDevice Type | Mouthguard,Over-the-Counter | Mouthguard, Over-the-Counter | None |
|---|---|---|---|
| Regulation | N/A | N/A | None |
| Product Code | OBR | OBR | None |
| ApplicablePerformanceStandards orSpecial Controls | None specified byFDA for ProductCode OBR | None specified byFDA for ProductCode OBR | None |
| DEVICE DESCRIPTION – SUBSTANTIAL EQUIVALENCE COMPARATORS | |||
| Intended Use | Keep upper andlower teethseparated duringsleep. | Keep upper andlower teethseparated duringsleep. | None |
| OTC or Rx | OTC | OTC | None |
| Indications for Use | For protectionagainst bruxism ornighttime teethgrinding. It isintended to reducedamage to theteeth and reducethe noiseassociated withbruxing or grinding. | Ready-FitDisposable DentalGuard is indicatedfor protection fornighttime teethgrinding or bruxism.It is intended toreduce damage toteeth by cushioningthem and keepingthem apart duringgrinding. | None |
| Target Population | Adults 18 and older | Adults 18 and older | None |
| Duration of Use | 1-3 days | 1 day | Minor (testing conducted toconfirm durability to 3 days, seeSection 18 - Bench Testing) |
| TechnologicalCharacteristics | Flexible guard usedas a barrierbetween teeth. | Flexible guard usedas a barrier betweenteeth. | None |
| DEVICE DESCRIPTION - DESIGN FEATURES | |||
| Material(s) | Ethylene/vinylacetate copolymer) | Ethylene/methylacrylate copolymer) | Minor (biocompatibility testingconfirmed the DenTek™ FreshProtect™ resin is appropriate forthis intended use) |
| Design /Presentation | Full occlusion,ready-to-weardental guard | Posterior occlusion,ready-to-weardental guard | Minor (the full occlusion design iscommon in OTC dental guards) |
| Method of | Injection molding | Injection molding | None |
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| Manufacture | |||
|---|---|---|---|
| Method of Cleaning | Rinse with waterbefore first use; ifusing for morethan one night,wash between usesand inspect forsigns of wear. | The device is meantto be discardedafter one night'suse. No instructionsfor cleaning areincluded. | Minor (the basic cleaninginstruction provided are similarto those seen on other OTCdental guards) |
| Fit | One size fits all | One size fits all | None |
| Dimensions (L x W xH) | 39.3 mm x 58 mm x8.35 mm | 38 mm x 39 mm x19 mm | Minor (similar to the predicate) |
| Weight | 0.79 grams (0.03ounces) | 1.13 grams (0.04ounces) | Minor (similar to the predicate) |
| Accessories | None | None | None |
| Sterile Device | No | No | None |
| Use environment | Home | Home | None |
| Anatomical site ofuse | Oral Cavity | Oral Cavity | None |
The table above identifies a few minor differences between the proposed device and the cited predicate. While the contact material for both devices is an ethylene-based copolymer, the exact resins are not identical; the appopriateness of the subject device's resin for use in a dental guard was demonstrated through biocompatability testing of the finished guards, which is provided in this application. Also, while both guards are labeled as "disposable" due to the short term intended use of each individual guard, the specific durations of use per the products' labeling differs: 1 day for the predicate and 1-3 days for the proposed device; this difference is minor because the DenTek™ Fresh Protect™ Dental Guard was shown adequately durable in a 3-day use simulation, the report for which is provided with this application. Another minor difference is that the predicate utilizes a posterior-occlusion design where the subject device – like many other OTC dental guards (refer to K091660 and K083400) - utilizes a full-occlusion design. Finally, though not identical, the measurements of the proposed guard are similar to the cited predicate (i.e., the resting bite radius is wider than the predicate because the predicate has a narrow strap between the bite pads that does not retain its in-use width) with a lower overall weight as intended to deliver an ultra-light guard.
In accordance with section 513(i)(1)(A) of the FDCA, a device is substantially equivalent (SE) when it has the same intended use and technological characteristics as a legally marketed predicate device. As demonstrated in this traditional 510(k), any differences between the subject device and the cited predicate do not raise different questions of safety or effectiveness and this application establishes that the device is as safe and effective as the predicates.
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8. Non-Clinical Performance Data
The following bench testing was conducted to confirm the performance of the DenTek™ Fresh Protect™ Dental Guard:
- Separation test. Simulation study demonstrating the finished guard's ability to keep the ● teeth separated when the jaw is clenched.
- . Fit test. Simulation study demonstrating the finished guard's ability to accommodate a range of arch widths without heating or adjustments.
- . Wear test. Simulation study demonstrating the finished guard's durability for the intended use duration of 1-3 days.
The non-clinical testing of DenTek™ Fresh Protect™ Dental Guard demonstrates the device's performance in providing teeth separation, accommodating different mouth sizes, and lasting the expected use life, which supports its substantial equivalence to the cited predicate.
Additionally, the following tests for biocompatibility were conducted on both the DenTek™ Fresh Protect ™ Dental Guard and the provided forming tray:
- In Vitro Cytotoxicity Assay (Elution method) in accordance with ISO 10993-5; ●
- . Guinea Pig Maximization Test (Sensitization) in accordance with ISO 10093-10, Section 7.5 and Annex E;
- . Oral Mucosa Irritation Test in accordance with ISO 10993-10 Annex B.3.
These studies demonstrated that the DenTek™ Fresh Protect ™ Dental Guard is not cytotoxic, is not a contact skin sensitizer, and is not irritating to the buccal mucosa, which further supports the device's substantial equivalence to the predicate.
9. Clinical Performance Data
There are no differences in intended use and technological characteristics between the DenTek™ Fresh Protect™ Dental Guard and the predicate that necessitate conducting a clinical trial.
10. Statement of Substantial Equivalence
As demonstrated in this application, the proposed device, the DenTek™ Fresh Protect™ Dental Guard, has the same intended use as the identified predicate device, the DenTek™ Ready-Fit™ Dental Guard (K151149), and employs the same basic technological characteristics; any differences between the proposed device and the predicates are minor and do not constitute different technological characteristics. The relevant information on biocompatibility and the performance testing confirm the DenTek™ Fresh Protect™ Dental Guard fulfills its intended use as safely and effectively as the legally marketed predicate device. The DenTek Fresh Protect™ Dental Guard is therefore substantially equivalent to the cited predicate.
N/A