Grind No More 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.

Device Description

Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band.

AI/ML Overview

This document is a 510(k) summary for Placontrol, Inc.'s "Grind No More" mouthguard. It states that the device is substantially equivalent to a predicate device and provides its intended use. However, it does not describe any specific acceptance criteria or an analytical study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard, K072147), rather than providing detailed performance data against specific acceptance criteria.

Therefore, the following requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The submission argues substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than specific performance metrics against pre-defined acceptance criteria.
Sample sized used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set is described.
Adjudication method for the test set: Not applicable as no test set is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mouthguard, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mouthguard, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific test data or ground truth establishment is described. The basis for approval is substantial equivalence to a predicate device.
The sample size for the training set: Not applicable as no training set is described.
How the ground truth for the training set was established: Not applicable as no training set is described.

Summary from the document:

The document outlines the regulatory submission for a Class I unclassified medical device (mouthguard). The core of the submission is a claim of substantial equivalence to a predicate device (DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147)). The arguments for substantial equivalence are based on:

Same intended uses and similar indications: "Grind No More 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." which is similar to the predicate device.
Similar technological characteristics: Both devices are posterior-only occlusive mouthguards with two molar bite plates connected by a buccal retention band.
Similar principles of operation.

The FDA found the device substantially equivalent for the stated indications for use, without requiring specific performance testing against pre-defined acceptance criteria as would be expected for a device with novel technology or higher risk classification.

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K082301". The characters are written in a simple, clear style, making them easily readable.

510(k) SUMMARY

Placontrol, Inc.'s Grind No More

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

Jonathan S. Kahan Regulatory Counsel to Placontrol, Inc. Hogan & Hartson LLP 555 Thirteenth Street, N.W. Washington, DC 20004

Phone: (202) 637-5794 Facsimile: (202) 637-5910

Date Prepared: August 12, 2008

Name of Device and Name/Address of Sponsor

Grind No More Placontrol, Inc. 12760 High Bluff Drive, Suite 210 San Diego, CA 92130

Common or Usual Name

Mouthguard

Classification Name

Mouthguard, Over-the-Counter

Product Code and CFR Provision

OBR, unclassified

Predicate Device

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

Intended Use / Indications for Use

Grind No More 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.

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Technological Characteristics

Grind No More is a posterior-only occlusive mouthguard, consisting of two molar bite plates connected by a buccal retention band. Similarly, the predicate device consists of two molar bite areas connected by a retaining band; therefore, the Grind No More device is technologically similar to the predicate device. As a safety feature to aid in device retention, each molar bite plate is grooved with vertical positioners to engage the natural anatomy of the teeth.

Substantial Equivalence

Grind No More is as safe and effective as the predicate device. Grind No More has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between Grind No More and its predicate device raise no new questions of safety or effectiveness. Thus, Grind No More is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned above three wavy lines, which may represent the nation's waters or the flow of health services. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

U 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Placontrol, Incorporated C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson LLP 555 Thirteenth Street. NW Washington, DC 20004

Re: K082301

Trade/Device Name: Grind No More Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: August 12, 2008 Received: September 18, 2008

Dear Mr. Kahan:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Whomels Land, md for 11

Chiu S. Lin, Ph. D Division 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): K082301

Device Name: Grind No More

Indications for Use:

Grind No More 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunne

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

510(k) Number: _ - 14 - Page 1 of 1

Regulation Number and Section

N/A