The Doctor's® NightGuard™ Advanced Comfort™ 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 grinding.

Device Description

The Doctor's® NightGuard™ Advanced Comfort™ is composed of a soft, formable clear upper material, made of ELVAX® resin (a copolymer of ethylene and viny) acetate) and ELVALOY® (a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate). When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (The Doctor's® NightGuard™ Advanced Comfort™) and explicitly states that "No performance data is required in support of this Special 510(k) notice." This means that no specific study, acceptance criteria, or performance metrics were submitted or evaluated for this particular device in this submission. The device's clearance was based on substantial equivalence to predicate devices, not on new performance data demonstrating its effectiveness.

Therefore, I cannot provide the requested information. If this were a device requiring performance data, the following would be applicable:

Hypothetical Example (if performance data were required):

If this were a device that required performance data, the acceptance criteria and study details would typically be presented as follows. This is a template of what one might expect if a study had been performed and reported.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., for reduction in bruxism episodes, bite-force distribution, material durability)	Reported Device Performance	Meets Criteria?
[Example criterion: Reduce average daily bruxism episodes by 50% compared to baseline]	[Example performance: Average daily bruxism episodes reduced by 65%]	Yes
[Example criterion: Maintain structural integrity for 6 months of typical use]	[Example performance: No structural degradation observed in 95% of devices after 6 months]	Yes
[Example criterion: Achieve a comfort rating of ≥ 4 out of 5 on a subjective user scale]	[Example performance: Average comfort rating of 4.2]	Yes
[Add more criteria as relevant to the device's function]	[Add corresponding performance data]	[Yes/No]

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: [e.g., 100 participants, 500 images]
Data Provenance: [e.g., Retrospectively collected data from a dental clinic in the USA, Prospectively collected data from a multi-center trial in Europe and North America]

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Number of Experts: [e.g., 3]
Qualifications of Experts: [e.g., Board-certified Prosthodontists with an average of 15 years of experience in craniomandibular disorders, Dentists specializing in sleep medicine with ≥10 years of experience]

4. Adjudication Method (Test Set)

Adjudication Method: [e.g., 2+1 (two experts independently review and if they disagree, a third expert adjudicates), Majority vote among 3 experts, None (single expert review)]

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

Was a MRMC study done? [Yes/No]
If Yes, effect size of human readers with vs. without AI assistance: [e.g., Clinicians demonstrated a 15% improvement in diagnostic accuracy with AI assistance compared to without AI assistance, or The mean time to diagnosis decreased by 20% when using the AI tool while maintaining non-inferior accuracy.]

6. Standalone Performance Study (Algorithm Only)

Was a standalone performance study done? [Yes/No]
If Yes, summary of results: [e.g., The algorithm achieved a sensitivity of 92% and specificity of 88% for detecting bruxism events when evaluated against polysomnography data.]

7. Type of Ground Truth Used

Type of Ground Truth: [e.g., Expert consensus based on clinical examination and patient interviews, Diagnosis confirmed by sleep study (polysomnography) results, Objective measurements from force sensors, Patient-reported outcomes verified by follow-up clinical assessments.]

8. Sample Size for Training Set

Sample Size for Training Set: [e.g., 500 patient records, 10,000 images, 200 hours of physiological signals]

9. How Ground Truth for Training Set Was Established

Method for Establishing Training Set Ground Truth: [e.g., Annotated by a single experienced prosthodontist, Labeled based on confirmed clinical diagnoses from patient charts, Derived from validated questionnaires and objective sensor data.]

Summary

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

K 073220

Special 510(k) SUMMARY

DEC 1 9 2007

1. Submitter's Name:	Dental Concepts, LLC
Address:	90 North Broadway, Irvington, New York 10533
Telephone Number.	(914) 524-6842
Contact Person:	Karen A. Costa-Strachan, Ph.D.
Date Prepared:	November 14, 2007

1. Device Name: Proprietary Name: The Doctor's® NightGuard™ Advanced Comfort™ Common or Usual Name: Dental Protector (Over-the-Counter) Classification Name: Unclassified Product Code: OBR
1. Devices to Which Substantial Equivalence is Claimed:

Primary Predicate Device: Dental Concepts The Doctor's® NightGuard™ Classic™ (K053580)

Secondary Predicate Device: Dental Concepts BruxGuard™ (K024261)

4. Device Description and Technological Characteristics:

5. Intended Use Statement:

6. Performance Data:

No performance data is required in support of this Special 510(k) notice.

7. Substantial Equivalence:

Doctor's® NightGuard™ Advanced Comfort™ possesses the same The technological characteristics, principles of operation and intended use as the predicate devices (currently marketed The Doctor's® NightGuard™ Classic™ and BruxGuard™) . Therefore, The Doctor's® NightGuard™ Advanced Comfort™ is substantially equivalent to both predicate devices.

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

Image /page/1/Picture/1 description: The image shows the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is black and the background is white.

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter.

DEC 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Costa-Strachan, Ph.D. Director Regulatory Affairs Prestige Brands, Incorporated 90 N Broadway Irvington, New York 10533

Re: K073220

Trade/Device Name: The Doctor's® NightGuard™ Advanced Comfort™ Regulation Number: None Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: OBR Dated: November 14, 2007 Received: November 23, 2007

Dear Dr. Costa-Strachan:

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.

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

Page 2 -- Dr. Costa-Strachan

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

Sincerely yours,

Chiu Lin, Ph.D.

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

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

K073220
28

INDICATIONS FOR USE STATEMENT

to prevent the noise associated with bruxing or grinding.

Applicant:	Dental Concepts, LLC
510(k) Number (if known):
Device Name:	The Doctor's® NightGuard™ Advanced Comfort™
Indications for Use:	The Doctor's® NightGuard™ Advanced Comfort™ is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and

Sue Cumpe

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ 073200

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-the-Counter Use or (Per 21 CFR 801.109)

PROPRIETARY DATA: This document and information on be reproduced, used or disclosed without written permission of Dental Concepts, LLC.

Regulation Number and Section

N/A