The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Description

Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band.

AI/ML Overview

This submission is a Special 510(k) for a modified device. Special 510(k)s rely on a comparison to a predicate device and declarations of similarity rather than new clinical studies to demonstrate safety and effectiveness. Therefore, the information typically found in clinical studies (like acceptance criteria, sample sizes, ground truth establishment, etc.) is not present in this document.

Here's a breakdown based on the provided text:

No specific acceptance criteria or device performance data from a clinical study are reported in this document. The submission is focused on demonstrating substantial equivalence to predicate devices, not on validating performance against predetermined criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
(Not specified as this is a Special 510(k) based on substantial equivalence to predicate devices)	(Not specified as this is a Special 510(k) based on substantial equivalence to predicate devices)

The document states: "Grind No More 2 and Grind No More 3 are as safe and effective as the predicate devices. Grind No More 2 and Grind No More 3 have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More 2, Grind No More 3, and the predicate devices raise no new questions of safety or effectiveness." This statement is the primary form of "performance" assessment in this type of submission.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No new test set or clinical study was conducted.
Data Provenance: Not applicable. The submission relies on a comparison to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set requiring ground truth establishment was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No new test set requiring adjudication was used.

5. 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 physical nightguard, not an AI-powered diagnostic tool. MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical nightguard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No new ground truth was established; the submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI or software algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" in this context is a Special 510(k) submission designed to demonstrate substantial equivalence between the modified devices (Grind No More Version 2 and Version 3) and previously cleared predicate devices (Placontrol, Inc.'s Grind No More (K082301) and DenTek Oral Care, Inc.'s Comfort Fit NightGuard (K072147)).

The core argument is that:

The intended uses are the same: "protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding."
Technological characteristics are similar: "posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band."
Principles of operation are similar.
"Minor technological differences" between the new and predicate devices "raise no new questions of safety or effectiveness."

Therefore, the "device meets the acceptance criteria" in the sense that the FDA has determined it is substantially equivalent to legally marketed predicate devices, implying it is as safe and effective. This determination is based on a comparative analysis of device characteristics, not on new clinical performance data.

Summary

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K091175

510(k) SUMMARY

Ranir, LLC's Grind No More Version 2 and Grind No More Version 3

MAY - 8 2009

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

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

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

Date Prepared: April 22, 2009

Name of Device and Name/Address of Sponsor

Grind No More Version 2 and Grind No More Version 3

Ranir, LLC 4701 East Paris Avenue SE Grand Rapids, MI 49512 (616) 698-8880 Phone: Facsimile: (616) 656-7650

Common or Usual Name

Nightguard

Classification Name

ﺮ

Mouthguard, Over-the-Counter

Classification Product Code

OBR

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Predicate Devices

Placontrol, Inc.'s Grind No More (K082301) DenTek Oral Care, Inc.'s Comfort Fit NightGuard (K072147)

Purpose of the Special 510(k) notice.

The Grind No More Version 2 and Grind No More Version 3 are modifications to Placontrol's Grind No More (K082301).

Intended Use

Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Technological Characteristics

Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band. Similarly, the predicate devices consist of two molar bite areas connected by a retaining band; therefore, the Grind No More 2 and Grind No More 3 devices are technologically similar to the predicate devices. As with the predicate Grind No More 1, the molar bitc plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention.

Substantial Equivalence

Grind No More 2 and Grind No More 3 are as safe and effective as the predicate devices. Grind No More 2 and Grind No More 3 have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More 2, Grind No More 3, and the predicate devices raise no new questions of safety or effectiveness. Thus, Grind No More 2 and Grind No More 3 are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Public Health Service

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ranir LLC C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan and Hartson LLP 555 Thirteenth Street, N.W. Washington, District of Columbia 20004

Re: K091175

Trade/Device Name: Grind No More Version 2 and Grind No More Version 3 Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: OBR Dated: April 22, 2009 Received: April 22, 2009

Dear Mr. Kahan:

We have reviewed your Scction 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 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. Kahan

Please be advised that FDA's issuance of a substantial cquivalence 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

Susan Runner, D.D.S., M.A.

Susan Runner, D.D.S., M.A Acting 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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K0911:75

Indications for Use Statement

510(k) Number (if known):

Device Name: Grind No More Version 2 and Grind No More Version 3

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)

Susan Gunser

: Ion Sign-Off) .slon of Anesthesiology, General Hospital nection Control, Dental Devices

510(k) Number

Regulation Number and Section

N/A