The DenTek Comfort Fit is indicated for use 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.

Device Description

The Comfort Fit consists of two bite pads and one buccal retaining strap. The bite pads consist entirely of Elvax, and the buccal retaining strap consists of Elvaloy. The bite pads move along the buccal strap to adjust to the individual user needs with the strap always contained within the wings of the bite pads. There are 4 positions of adjustability for each molar pad. There is a built in wear indicator, which helps the user determine when they need to replace their Comfort Fit.

AI/ML Overview

This premarket notification (K072147) for DenTek's Comfort Fit NightGuard is a Special 510(k) notice. This means the submission focuses on modifications to an already cleared device and demonstrates substantial equivalence to predicate devices, rather than establishing a completely new device's safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed clinical study information typically found in a traditional 510(k) or a PMA where new acceptance criteria and their proof are established.

Based on the provided text, the device's acceptance criteria are framed within the context of substantial equivalence to predicate devices rather than performance metrics from a specific study designed to meet predetermined acceptance thresholds.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Basis)	Reported Device Performance (Inferred from Description)
Intended Use: Protection against bruxism or nighttime teeth grinding, reduction of damage to teeth, prevention of noise.	Intended Use: Same as predicate devices. The Comfort Fit is "indicated 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 teeth grinding."
Technological Characteristics: Similar materials, design, and operating principles to predicate devices.	Technological Characteristics: Consists of "two bite pads and one buccal retaining strap." Bite pads are "Elvax," and the strap is "Elvaloy." Features "4 positions of adjustability for each molar pad" and a "built-in wear indicator." These are presented as modifications consistent with the function of predicate devices.
Material Safety & Biocompatibility: Materials used should be safe for oral contact (implied by use of Elvax and Elvaloy, likely established for predicate devices).	Material Safety & Biocompatibility: Elvax and Elvaloy are specified. These materials are generally recognized as safe for medical devices and are likely similar or identical to materials used in the predicate devices.
Performance (implicitly): Device should effectively protect against bruxism, reduce damage, and prevent noise without causing harm.	Performance (implicitly): The "Comfort Fit is a modification to the DenTek NightGuard" (predicate K063483). The claim of substantial equivalence implies that the Comfort Fit performs comparably to the predicate devices in fulfilling its intended use. No specific quantitative performance metrics (e.g., reduction in grinding force, duration of wear) are provided.

2. Sample Size Used for the Test Set and Data Provenance

None stated. This submission is a Special 510(k) for modifications and relies on demonstrating substantial equivalence to predicate devices. It does not present a new clinical study with a "test set" in the traditional sense. The comparison is primarily based on intended use, technological characteristics, and potentially material safety data if new materials were introduced (which doesn't appear to be the case for the type of material, just potentially a formulation or processing).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No external "ground truth" establishment from experts is mentioned in this type of submission. The FDA reviews the provided information and determines substantial equivalence based on regulatory guidelines.

4. Adjudication Method for the Test Set

Not applicable. No test set or independent adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed/reported. This is not a study design relevant to a mechanical device like a nightguard in a Special 510(k) submission. MRMC studies are typically for diagnostic imaging devices where human readers interpret images with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not performed/reported. This device is a physical product, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Not applicable for a new ground truth. The "ground truth" here is essentially the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance and market history. The Comfort Fit aims to show it is as safe and effective as these predicates.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission. The device is a physical nightguard.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, no training set or associated ground truth establishment process is relevant to this submission.

In summary:

This Special 510(k) provides information to demonstrate that DenTek's Comfort Fit NightGuard is substantially equivalent to legally marketed predicate devices. The "proof" that the device meets "acceptance criteria" is the argument of this substantial equivalence based on its intended use, similar indications, principles of operation, and technological characteristics (including materials and adjustment features). It is not based on a new clinical study with performance metrics against predefined acceptance criteria.

Summary

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K072147

DenTek's Comfort Fit

AUG 3 0 2007

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

John Jansheski DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 (865) 983-2444 Facsimile:

OR

Howard Holstein, Esq. Hogan and Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington, DC, 20004 Phone: (202) 637-5813 Facsimile: (202) 637-5910

Date Prepared: July 27, 2007

Name of Device and Name/Address of Sponsor

DenTek's Comfort Fit NightGuard DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 Phone: (865) 983-1300 Facsimile: (865) 983-2444

Common or Usual Name

Nightguard

Classification Name

Unclassified

Predicate Devices

DenTek Oral Care, Inc.'s NightGuard (K063483)

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Power Product Inc.'s Splintek EZ-Splint (K022809)

Purpose of the Special 510(k) Notice

The Comfort Fit is a modification to the DenTek NightGuard.

Intended Use

The Comfort Fit is indicated 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 teeth grinding.

Technological Characteristics

Substantial Equivalence

The Comfort Fit has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate devices. Thus, the Comfort Fit is substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DenTek Oral Care, Incorporated C/O Mr. Howard M. Holstein, Esq. Regulatory Counsel Hogan & Hartson, L.L.P 555 13" Street NW Washington, DC 20004

AUG 3 0 2007

Re: K072147

Trade/Device Name: DenTek Comfort Fit NightGuard Regulation Number: Unclassified Regulation Name: Not Applicable Regulatory Class: Unclassified Product Code: OBR Dated: August 3, 2007 Received: August 3, 2007

Dear Mr. Holstein:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Holstein

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sudite y. Michie Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Konz147

Attachment 9

Indications for Use Statement

Device Name: DenTek Comfort Fit NightGuard

Indications for Use: The DenTek Comfort Fit is indicated for use 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.

Prescription Use (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use X (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Ruar
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072147

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Regulation Number and Section

N/A