Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and molding process of a dental guard, with no mention of AI or ML technologies.

Therapeutic

No

This device is intended to reduce damage and noise associated with bruxism, not to treat the underlying condition itself.

Diagnostic

No

This device is designed to protect against the effects of bruxism (teeth grinding), not to diagnose the condition itself. Its function is to reduce damage and noise, and it does not perform any assessment or identification of bruxism.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical dental guard made of thermoplastic material, requiring molding and placement in the oral cavity. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the DenTek Ultimate™ Dental Guard is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
DenTek Ultimate™ Dental Guard Function: The description clearly states that this device is a physical guard placed in the mouth to protect against teeth grinding. It does not perform any tests on bodily samples.
Intended Use: The intended use is for physical protection and reduction of damage and noise, not for diagnostic purposes.
Device Description: The description focuses on the physical construction and fitting process of the guard.
Performance Studies: The performance studies described are related to the physical properties and biocompatibility of the device, not diagnostic accuracy.

Therefore, the DenTek Ultimate™ Dental Guard falls under the category of a physical medical device used for protection and treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

OBR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Adults 18 and older

Intended User / Care Setting

lay people to reduce the damage caused by nighttime teeth grinding. (Home)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

DenTek™ Custom Comfort Nightguard Version 2 (K091660)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K123849

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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3

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510(k) Summary

DenTek Ultimate™ Dental Guard

K # 180933

1. Submitter

| Name & Address: | Medtech Products Inc.
660 White Plains Road
Tarrytown, NY, 10591 |
|-------------------------|------------------------------------------------------------------------|
| Contact: | Vincent Argiro, RAC |
| Title:
Phone number: | Director, Regulatory Affairs
(914) 524-8721 |
| Email: | vargiro@prestigebrands.com |

1. 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
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 /
Device Name	DenTek Ultimate™
Dental Guard	DenTek™ Custom
Comfort Night
Guard Version 2	DenTek™ New
Comfort-Fit®
Dental Guard	N/A
510(k) Number	K180933	K091660	K123849	N/A
Date Cleared	90 days from date
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
Device Type	Mouthguard,
Over-the-Counter	Mouthguard,
Over-the-Counter	Mouthguard,
Over-the-Counter	None
Regulation	N/A	N/A	N/A	None
Product Code	OBR	OBR	OBR	None
Applicable
Performance
Standards or
Special Controls	None specified by
FDA for Product
Code OBR	None specified by
FDA for Product
Code OBR	None specified by
FDA for Product
Code OBR	None
DEVICE DESCRIPTION - SUBSTANTIAL EQUIVALENCE COMPARATORS
Intended Use	Keep upper and
lower teeth
separated during
sleep.	Keep upper and
lower teeth
separated during
sleep.	Keep upper and
lower teeth
separated during
sleep.	None
OTC or Rx	OTC	OTC	OTC	None
Indications for Use	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.	For protection
against bruxism or
nighttime teeth
grinding. It is
intended to reduce
damage to the
teeth and to
prevent the noise
associated with
bruxing or
grinding.	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.	None
Target Population	Adults 18 and
older	Adults 18 and
older	Adults 18 and
older	None
Technological
Characteristics	Flexible, moldable
guard used as a
barrier between
teeth.	Flexible, moldable
guard used as a
barrier between
teeth.	Flexible, adjustable
guard used as a
barrier between
teeth.	Same as predicate
DEVICE DESCRIPTION - DESIGN FEATURES
Contact Materials	Ethylene-vinyl
acetate copolymer	Ethylene-vinyl
acetate copolymer	Ethylene-vinyl
acetate copolymer	Minor (similar to
both cited devices)
Other Materials	None	Ethylene and
methyl acrylate
copolymer	None	Same as reference
Design /	Posterior	Full occlusion, boil-	Posterior	Minor (similar to
both cited devices)

6

| Presentation | occlusion, boil-
and-fit dental
guard | and-fit dental
guard | occlusion, ready-
to-wear dental
guard | both cited devices) |
|---------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Method of
Manufacture | Injection molding | Injection molding | Injection molding | None |
| Method of Cleaning | Toothpaste or
mouthwash, brush
followed by cool
water rinse. | Toothpaste or
mouthwash, brush
followed by cool
water rinse. | Toothpaste or
mouthwash, brush
or effervescent
cleaning
tablet/powder
followed by cool
water rinse. | Same as predicate |
| Fit | One size fits all via
traditional heat
and bite. | One size fits all via
traditional heat
and bite. | One size fits all via
adjustable bite
pad-position. | Same as predicate |
| Dimensions (L x W x
H) | 30.1 mm x 61.9
mm x 12.01 mm | 42 mm x 64.8 mm
x 11.15 mm | 40 mm – 48 mm x
42 mm x 16 mm | Minor (similar to
both cited devices) |
| Weight | 3.2 grams | 7.8 grams | 2.5 grams | Minor (similar to
both cited devices) |
| Fitting Tray
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
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.