The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower incisors and an internal layer, which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and the inner, moldable layer consists of polycaprolactone.

AI/ML Overview

The provided document is a 510(k) summary for the GrindGUARDN mouthguard, which is a traditional submission asserting substantial equivalence to predicate devices. It describes the device, its intended use, and lists predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory submission process and the determination of substantial equivalence, not on the results of performance studies against specific acceptance criteria.

Summary

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AUG 3 1 2009

GrindGUARDN

6.0 510(K) SUMMARY

Manufacturer	Grind Guard Technologies LLC
Contact Name	Dr. Joseph Pelerin
Postal Address	4498 Klais Dr.Clarkston MI 48348
Phone Number	248-391-1625
Fax	248-391-1727
E-mail	contact@advantagedentlinc.com
Title	President and CEO
Date	September 15,2008

Proprietary Name	GrindGUARDN
Common Name	Mouthguard
Classification Name	Mouthguard, Prescription
Classification Code	MQC

Predicate Devices

Substantial equivalence is being claimed to:

The Doctor's Nightguard Advanced Comfort (K073220)
. NTI Tension Suppression System (K010876)
TAP- anti-snoring device ( formerly Quiet Knight) (K962516) .
. Temporary Crown Matrix Buttons (K900389)

Description of Device

Intended Use

The GrindGUARD, is a mouth guard intended to protect against grinding and clenching.

Traditional 510 (k) Submission

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 81 2009

Grind Guard Technologies, LLC Mr. Bill McLain Principal Consultant Keystone Regulatory Services, LLC 342 East Main Street, Suite 207 Leola, Pennsylvania 17540

Re: K082723

Trade/Device Name: GrindGUARDN Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: August 17, 2009 Received: August 20, 2009

Dear Mr. McLain:

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 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 - Mr. McLain

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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/Reporta Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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GrindGUARDN

Grind Guard Technologies, LLC

SECTION 5. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Indications for Use:

GrindGUARDN

The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A