(63 days)
Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch, as a protection for those who suffer form the night time grinding of the teeth. 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 during nocturnal bruxing.
The provided text is a 510(k) summary for the Grind Guard device. A 510(k) submission is typically for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive studies in the same way a novel high-risk device might.
The information provided does not include a detailed study that defines "acceptance criteria" for the Grind Guard's performance or a study demonstrating the device meets such criteria. The submission focuses on showing substantial equivalence to a predicate device based on indications for use, technological characteristics, principle of operation, and material.
Therefore, many of the requested items (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) are not available in the provided text, as they are not typically required for a 510(k) submission of this type.
Here’s a breakdown of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., in terms of effectiveness for reducing bruxism, preventing tooth damage, or reducing noise)
are provided in the document. The submission is based on substantial equivalence to a predicate device, implicitly meaning it is expected to perform similarly to the predicate without requiring a new detailed performance study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance studies or test sets are described. The submission is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No performance studies or ground truth establishment for a test set are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance studies or test set adjudication are described.
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. The Grind Guard is a medical device, not an AI software, and no comparative effectiveness study, MRMC, or human reader assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Grind Guard is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance studies or ground truth are described. The basis for approval is substantial equivalence to the predicate device, which implies the predicate was deemed safe and effective for its stated indications.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is described.
Summary of Device and Approval Process from the Text:
- Device Name: Grind Guard
- Intended Use: Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
- Device Type: Mouthguard, Over-the-Counter
- Approval Method: 510(k) Premarket Notification, which demonstrates substantial equivalence to a predicate device.
- Predicate Device: Doctor's Night Guard (K053580) by Dental Concepts.
- Basis for Equivalence: Indications for use, general technological characteristics, principle of operation, and material.
- Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed subject to general controls.
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Kom3446
Premarket Notification - Grind Guard
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
Date Summary Prepared: December 31, 2008
Contact Person:
Ian P. Gordon, Senior Vice President Emergo Group, Inc. 1705 S. Capital of Texas Hwy., Suite 500 Austin, Texas, 78746 Telephone: 512.327.9997 Fax: 512-327-9998
Device Name:
Trade Name(s): Grind Guard Classification Name: Mouthguard, Over-the-Counter Panel: Dental Product Code: OBR
Section 10 - Executive Summary
Device Description:
The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch, as a protection for those who suffer form the night time grinding of the teeth. 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 during nocturnal bruxing.
Indications for Use:
Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
Predicate Device Information:
This device is substantially equivalent to the Doctor's Night Guard, marketed by Dental Concepts under K053580.
Comparison to Predicate Device(s):
The Grind Guard is substantially equivalent with regard to indications for use, general technological characteristics, principle of operation, and material.
FEE - 8
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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 consists of a stylized caduceus, which is a symbol of medicine, with a double helix intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
FEB -- 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Archtek, Incorporated C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K073446
Trade/Device Name: Grind Guard Regulation Number: None Regulation Name: Unclassified Regulatory Class: None Product Code: OBR Dated: December 6, 2007 Received: December 11, 2007
Dear Mr. Gordon:
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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Page 2 - Mr. Gordon
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 (OS) 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
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073446
Indications for Use
510(k) Number (if known): ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Grind Guard
Indications for Use: Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use XX (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)
Clu
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073446
N/A