GRIND GUARD

K090472 · Archtek, Inc. · MQC · Oct 14, 2009 · DE

Device Facts

• Record ID: K090472
• Device Name: GRIND GUARD
• Applicant: Archtek, Inc.
• Product Code: MQC · DE
• Decision Date: Oct 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

To protect against tooth damage bruxism and clenching caused by occlusal interferences, Provide short term relief from muscle spasm due to occlusal interferences, and Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.

Device Story

Grind Guard is a prescription-only, thermoformable dental appliance worn on the upper arch at night. Device consists of soft, shock-absorbing material molded to user's teeth to cushion against forces of bruxism and clenching. Intended for use by patients 18 years or older to mitigate tooth damage, muscle spasms, and temporomandibular joint pain. Operation involves heating and cooling the material to achieve a custom fit. Healthcare providers prescribe the device to manage symptoms of occlusal interference and chronic jaw clenching.

Clinical Evidence

Effectiveness supported by an independent clinical study published in JADA regarding the relief of orofacial pain associated with temporomandibular disorders.

Technological Characteristics

Soft, thermoformable material; shock-absorbing design; custom-molded to upper arch; non-athletic mouthguard; manual thermal fitting process.

Indications for Use

Indicated for adults (18+) for protection against tooth damage from bruxism/clenching, short-term relief of muscle spasms from occlusal interferences, and prevention of pain/tension associated with temporomandibular joint syndrome caused by chronic jaw clenching. Not for use as an athletic mouth guard.

Predicate Devices

• Archtek OTC Grind Guard (K073446)
• SleepRight adjustable night guard (K071404)

Submission Summary (Full Text)

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K090472

### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

### Submitter Information: Archtek, Inc. 12105 W. Cedar Dr.

Lakewood, CO 80228

OCT 1 4 2009

#### Date Summary Prepared: October 6, 2009

Contact Person: Krista Oakes Emergo Group, Inc. 1705 S. Capital of Texas Hwy., Suite 500 Austin, Texas, 78746

Telephone: [phone] Fax: [phone]

### Device Name:

Trade Name(s): Grind Guard Classification Name: Mouthguard, Prescription Panel: Dental Product Code: MQC

#### Device Description:

The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth; shock-absorbing material cushions teeth on all sides. This device may not be used as an athletic mouth guard. This device should not be used by persons under the age of 18.

#### Indications for Use:

Prescription indications:

To protect against tooth damage bruxism and clenching caused by occlusal interferences, ક્ષ.

Provide short term relief from muscle spasm due to occlusal interferences, and b.

Prevention of pain and chronic tension of temporomandibular joint syndrome components that are c. caused by chronic jaw clenching.

#### Predicate Device Information:

This device is substantially equivalent to the Archtek OTC Grind Guard cleared under K073446 and the SleepRight adjustable night guard, marketed as a prescription device by Splintek -- Power Products Inc. under K071404.

#### Comparison to Predicate Device(s):

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The Grind Guard is identical in design and material to the OTC device cleared under K073446. It is substantially equivalent with regard to prescription use and indications, general technological characteristics, principle of operation, and material to the prescription device cleared under K071404.

### Testing and Conclusions:

An independent clinical study published by JADA supports the effectiveness of the Grind Guard for the relief of orofacial pain associated with temporomandibular disorders.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of three stylized birds in flight, arranged vertically. The birds appear to be ascending or moving upwards.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Archtek. Incorporated Ms. Krista Oakes Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

Re: K090472

Trade/Device Name: Grind Guard Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: September 4, 2009 Received: September 26, 2009

# OCT 1 4 2009

## Dear Ms. Oakes:

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 2- Ms. Oakes

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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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K090472

Indications for Use

510(k) Number (if known):

Device Name: Grind Guard

Indications for Use (Rx):

To protect against tooth damage bruxism and clenching caused by occlusal a. interferences,

b. Provide short term relief from muscle spasm due to occlusal interferences, and

c. Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Kevin Msalen for MSR

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

510(k) Number: K090472