DenTek Ultimate Dental Guard

K180933 · Medtech Products, Inc. · OBR · Sep 17, 2018 · DE

Device Facts

• Record ID: K180933
• Device Name: DenTek Ultimate Dental Guard
• Applicant: Medtech Products, Inc.
• Product Code: OBR · DE
• Decision Date: Sep 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The DenTek Ultimate™ 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.

Device Story

One-piece, posterior-occlusion dental guard; thermoplastic ethylene-vinyl acetate copolymer construction. User-fitted at home via submersion in boiled water; pre-loaded in flexible molding tray for placement on maxillary pre-molars. Device maintains separation between upper and lower teeth during sleep; reduces noise and damage associated with bruxism. Used by lay people; no physician operation required. Benefits include protection of dental enamel and reduction of grinding-related noise.

Clinical Evidence

No clinical data. Bench testing only: impression, separation, stability, and comparative wear tests confirmed performance and six-month usable life. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-10 (oral mucosa irritation) confirmed non-cytotoxic, non-sensitizing, and non-irritating properties.

Technological Characteristics

Thermoplastic ethylene-vinyl acetate copolymer; posterior-occlusion design; boil-and-fit molding; injection molded; non-sterile; home-use; dimensions 30.1mm x 61.9mm x 12.01mm; weight 3.2g; biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for adults 18 and older for protection against bruxism or nighttime teeth grinding to reduce tooth damage and grinding noise.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

• DenTek™ Custom Comfort Nightguard Version 2 (K091660)

Reference Devices

• DenTek™ New Comfort-Fit® Dental Guard (K123849)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtech Products Inc. % Vincent Argiro Director Regulatory Affairs Prestige Brands Holdings 660 White Plains Road Tarrytown, New York 10591

Re: K180933

Trade/Device Name: DenTek Ultimate Dental Guard Regulatory Class: Unclassified Product Code: OBR Dated: August 8, 2018 Received: August 9, 2018

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 avare 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.

September 17, 2018

{1}------------------------------------------------

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

Device Name DenTek Ultimate Dental Guard

Indications for Use (Describe)

The DenTek Ultimate™ 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Medtech, a Prestige Brands company. The word "MEDTECH" is written in large, bold, blue letters. Below the word "MEDTECH" is a thin blue line, and below that is the phrase "A PrestigeBrands COMPANY", with the word "PrestigeBrands" in red and the rest of the phrase in blue.

# 510(k) Summary

# DenTek Ultimate™ Dental Guard

K # 180933

## 1. Submitter

| Name & Address: | Medtech Products Inc.<br>660 White Plains Road<br>Tarrytown, NY, 10591 |
|-------------------------|------------------------------------------------------------------------|
| Contact: | Vincent Argiro, RAC |
| Title:<br>Phone number: | Director, Regulatory Affairs<br>[phone] |
| Email: | [e-mail] |

- 2. Date Prepared September 14, 2018
#### 3. Device Identification

| Trade/Proprietary Name: | DenTek Ultimate™ 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<br>Dental Devices |

# 4. Legally Marketed Predicate Device(s)

| Primary Predicate: DenTek™ Custom Comfort Nightguard Version 2 (K091660), Product |
|-----------------------------------------------------------------------------------|
| Code OBR |

{4}------------------------------------------------

Reference Device:

### 5. Device Description

The DenTek Ultimate™ Dental Guard is a one-piece, posterior-occlusion dental guard consisting of two moldable bite-pads connected by a flexible band that rests behind the user's front teeth. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's maxillary pre-molars after the guard has been heated via submersion in boiled water. The DenTek Ultimate™ Dental Guard is supplied pre-loaded into a flexible molding tray that allows the user to accurately place and comfortably hold the heated device during the molding process. When in place, the guard maintains separation between upper and lower teeth, reducing noise and damage to the teeth associated with teeth grinding.

### 6. Intended Use

The DenTek Ultimate™ Dental Guard is an over-the-counter (OTC) device that is intended to be used by lay people to reduce the damage caused by nighttime teeth grinding.

The DenTek Ultimate™ Dental Guard bears the following indications for use statement:

The DenTek Ultimate™ 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 Ultimate ™ Dental Guard intended use statement is identical to that of the predicate devices.

## 7. Substantial Equivalence Discussion

The following table compares the DenTek Ultimate™ Dental Guard to the chosen predicate and reference devices 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 | Reference Device | Differences |
|-----------------------------|----------------------------------------|----------------------------------------------------|---------------------------------------------|-------------|
| Trade Name /<br>Device Name | DenTek Ultimate™<br>Dental Guard | DenTek™ Custom<br>Comfort Night<br>Guard Version 2 | DenTek™ New<br>Comfort-Fit®<br>Dental Guard | N/A |
| 510(k) Number | K180933 | K091660 | K123849 | N/A |
| Date Cleared | 90 days from date<br>of receipt by FDA | 06/12/2009 | 01/10/2013 | N/A |
| Original applicant | Medtech Products | DenTek Oral Care, | DenTek Oral Care, | N/A |

{5}------------------------------------------------

| | Inc. | Inc. | Inc. | |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| REGULATORY CLASSIFICATION | | | | |
| Regulatory Class | Unclassified | Unclassified | Unclassified | None |
| Name of Generic<br>Device Type | Mouthguard,<br>Over-the-Counter | Mouthguard,<br>Over-the-Counter | Mouthguard,<br>Over-the-Counter | None |
| Regulation | N/A | N/A | N/A | None |
| Product Code | OBR | OBR | OBR | None |
| Applicable<br>Performance<br>Standards or<br>Special Controls | None specified by<br>FDA for Product<br>Code OBR | None specified by<br>FDA for Product<br>Code OBR | None specified by<br>FDA for Product<br>Code OBR | None |
| DEVICE DESCRIPTION - SUBSTANTIAL EQUIVALENCE COMPARATORS | | | | |
| Intended Use | Keep upper and<br>lower teeth<br>separated during<br>sleep. | Keep upper and<br>lower teeth<br>separated during<br>sleep. | Keep upper and<br>lower teeth<br>separated during<br>sleep. | None |
| OTC or Rx | OTC | OTC | OTC | None |
| Indications for Use | For protection<br>against bruxism or<br>nighttime teeth<br>grinding. It is<br>intended to reduce<br>damage to the<br>teeth and reduce<br>the noise<br>associated with<br>bruxing or<br>grinding. | For protection<br>against bruxism or<br>nighttime teeth<br>grinding. It is<br>intended to reduce<br>damage to the<br>teeth and to<br>prevent the noise<br>associated with<br>bruxing or<br>grinding. | For protection<br>against bruxism or<br>nighttime teeth<br>grinding. It is<br>intended to reduce<br>damage to the<br>teeth and reduce<br>the noise<br>associated with<br>bruxing or<br>grinding. | None |
| Target Population | Adults 18 and<br>older | Adults 18 and<br>older | Adults 18 and<br>older | None |
| Technological<br>Characteristics | Flexible, moldable<br>guard used as a<br>barrier between<br>teeth. | Flexible, moldable<br>guard used as a<br>barrier between<br>teeth. | Flexible, adjustable<br>guard used as a<br>barrier between<br>teeth. | Same as predicate |
| DEVICE DESCRIPTION - DESIGN FEATURES | | | | |
| Contact Materials | Ethylene-vinyl<br>acetate copolymer | Ethylene-vinyl<br>acetate copolymer | Ethylene-vinyl<br>acetate copolymer | Minor (similar to<br>both cited devices) |
| Other Materials | None | Ethylene and<br>methyl acrylate<br>copolymer | None | Same as reference |
| Design / | Posterior | Full occlusion, boil- | Posterior | Minor (similar to<br>both cited devices) |

{6}------------------------------------------------

| Presentation | occlusion, boil-<br>and-fit dental<br>guard | and-fit dental<br>guard | occlusion, ready-<br>to-wear dental<br>guard | both cited devices) |
|---------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Method of<br>Manufacture | Injection molding | Injection molding | Injection molding | None |
| Method of Cleaning | Toothpaste or<br>mouthwash, brush<br>followed by cool<br>water rinse. | Toothpaste or<br>mouthwash, brush<br>followed by cool<br>water rinse. | Toothpaste or<br>mouthwash, brush<br>or effervescent<br>cleaning<br>tablet/powder<br>followed by cool<br>water rinse. | Same as predicate |
| Fit | One size fits all via<br>traditional heat<br>and bite. | One size fits all via<br>traditional heat<br>and bite. | One size fits all via<br>adjustable bite<br>pad-position. | Same as predicate |
| Dimensions (L x W x<br>H) | 30.1 mm x 61.9<br>mm x 12.01 mm | 42 mm x 64.8 mm<br>x 11.15 mm | 40 mm – 48 mm x<br>42 mm x 16 mm | Minor (similar to<br>both cited devices) |
| Weight | 3.2 grams | 7.8 grams | 2.5 grams | Minor (similar to<br>both cited devices) |
| Fitting Tray<br>Included | Yes | Yes | No | Same as predicate |
| Accessories | Storage case | Storage case | Storage case | None |
| Multiple Use Device | Yes | Yes | Yes | None |
| Sterile Device | No | No | No | None |
| Leaflet included | Yes | Yes | Yes | None |
| Use environment | Home | Home | Home | None |
| Anatomical site of<br>use | Oral Cavity | Oral Cavity | Oral cavity | None |

The table above identifies a few minor differences between the proposed device and the cited predicate and reference devices. While the contact material for all devices is an ethylene-vinyl acetate copolymer, the specific copolymer used in the proposed device has an ethylene-to-vinyl acetate ratio that falls between the ratios used in the predicate and reference devices. Also, the design of the proposed device blends the boil-and-fit molding method of the predicate with the posterior-occlusion format of the reference device. Finally, though not identical, the measurements of the proposed guard are similar to both cited devices (i.e., the bite radius and vertical profile dimensions are within 10% of the predicate device, but with a lesser depth due to the partialocclusion design, and the weight of the proposed product falls between the weights of the other two devices).

{7}------------------------------------------------

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 are minor and do not raise different questions of safety or effectiveness and this application establishes that the device is as safe and effective as the predicate. It is on this basis that DenTek Ultimate™ Dental Guard is SE to the cited predicate device.

# 8. Non-Clinical Performance Data

The following bench testing was conducted to confirm the performance of the DenTek Ultimate™ Dental Guard:

- . Impression test. Simulation study demonstrating the finished guard's ability to take a distinct impression of the teeth when molded as directed.
- . Separation test. Simulation study demonstrating the finished guard's ability to keep the teeth separated when the jaw is clenched.
- . Stability test. Simulation study demonstrating the finished guard's ability to stay in place after fitting.
- . Comparative wear test. Simulation study demonstrating the finished guard's durability is equivalent to that of the cited predicate device. (Note: This study was used to support the labeled six-month usable life of the DenTek Ultimate™ Dental Guard, which matches that of the predicate device.)

The non-clinical testing of DenTek Ultimate™ Dental Guard demonstrates the device's performance providing a distinct impression of the teeth, separation, security and expected use life and therefore supports the substantial equivalence to the cited predicate.

Additionally, the following tests for biocompatibility were conducted on both the DenTek Ultimate™ 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 DenTek Ultimate™ Dental Guard and the forming tray were not cytotoxic, were not contact skin sensitizers, and were 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 Ultimate Dental Guard and the predicate that necessitate conducting a clinical trial.

{8}------------------------------------------------

#### 10. Statement of Substantial Equivalence

As demonstrated in this application, the proposed device, the DenTek Ultimat™ Dental Guard, has the same intended use as the identified predicate device, DenTek™ Custom Comfort Nightguard Version 2 (K091660), and employs the same basic technological characteristics; any differences between the proposed device and the predicate are minor and do not constitute different technological characteristics. The relevant information on biocompatibility and the performance testing confirm the DenTek Ultimate™ Dental Guard fulfills its intended use as safely and effectively as the legally marketed predicate device. The DenTek Ultimate™ Dental Guard is therefore substantially equivalent to the cited predicate.