The DenTek Improved Comfort-Fit NightGuard 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 Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.

AI/ML Overview

The provided text is a 510(k) summary for the DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria and a detailed study proving the device meets those criteria.

Therefore, the information required in the prompt (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set sizes) is not available within this 510(k) summary.

Here's a breakdown of why this information is missing and what the document does provide:

Acceptance Criteria and Device Performance: The document does not describe specific performance metrics (e.g., reduction in tooth wear, noise reduction percentage) or a table of acceptance criteria. Its primary claim is that the "minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness."
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): This 510(k) is a Special 510(k) based on modifications to an already cleared device (K072147). For such submissions, manufacturers typically demonstrate that the changes do not adversely affect safety or effectiveness, often through engineering analysis, biocompatibility testing, and sometimes limited human factors or user preference studies, rather than large-scale clinical trials with extensive ground truth establishment. No such detailed study information is provided in this summary.
Ground Truth: Since there's no detailed study described, there's no mention of how "ground truth" would have been established for performance metrics. The implicit "ground truth" for substantial equivalence is the safety and effectiveness of the predicate device.
Training Set: This is not an AI/ML device, so there is no concept of a "training set" like in typical AI performance studies.

What the document does state regarding demonstrating equivalence (which is the goal of a 510(k)):

Purpose: The Improved Comfort-Fit NightGuard is a modification to DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147).
Intended Use: Identical to the predicate: protection against bruxism or nighttime teeth grinding, reduction of damage to teeth, and prevention of noise.
Technological Characteristics: Made entirely of ELVAX (a thermoplastic material), posterior-only occlusion, two bite pads connected by a buccal retention strap, 5 positions of adjustability for each molar pad. The previous version (K072147) would have had very similar characteristics. The "Improved Comfort-Fit" implies minor design changes for user experience rather than fundamental functional differences.
Substantial Equivalence Argument: "DenTek's Improved Comfort-Fit has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Comfort Fit. The minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness. Thus, the Improved Comfort-Fit is substantially equivalent to its predicate devices."

In summary, this 510(k) notification for a modified physical device does not contain the kind of performance study data and acceptance criteria you would find for an AI/ML diagnostic or treatment device. Its entire premise is that it's so similar to a previously cleared device that extensive new studies are not required to demonstrate safety and effectiveness.

Summary

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K081669

510(k) SUMMARY

JUL 1 0 2008

DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard

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

Howard M. Holstein, Esq. Hogan & Hartson LLP 555 13th Street NW Washington, DC 20004

(202) 637-5813 Phone: Facsimile: (202) 637-5910

June 13, 2008 Date Prepared:

Name of Device and Name/Address of Sponsor

Improved 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

Mouthguard, Over-the-Counter

Classification Product Code

OBR

Predicate Devices

DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)

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Purpose of the Special 510(k) notice.

The Improved Comfort-Fit NightGuard is a modification to DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147).

Intended Use

DenTek's Improved Comfort-Fit NightGuard 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.

Technological Characteristics

Substantial Equivalence

DenTek's Improved Comfort-Fit has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Comfort Fit. The minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness. Thus, the Improved Comfort-Fit is substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

JUL 10 2008

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 LLP 555 Thirteenth Street, NW Washington, DC 20004

Rc: K081669

Trade/Device Name: Improved Comfort-Fit NightGuard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 13, 2008 Received: June 13, 2008

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 your 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 Parl 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

A. Samuel S. Ford, m.D. Hor

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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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Improved Comfort-Fit NightGuard

Indications for Use:

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)

Robert S. Betz MS/for Dr. Susan Runner
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K08/669

Regulation Number and Section

N/A