NTI ClenchGuard

K211158 · Boyd Research, Inc. · OBR · Sep 17, 2021 · DE

Device Facts

• Record ID: K211158
• Device Name: NTI ClenchGuard
• Applicant: Boyd Research, Inc.
• Product Code: OBR · DE
• Decision Date: Sep 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing; 2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.

Device Story

NTI ClenchGuard is an oral appliance designed for use by patients to manage bruxism and associated migraine pain. The device acts as a physical barrier to prevent tooth-to-tooth contact during nighttime grinding or clenching. By reducing the intensity of clenching, it aims to alleviate tension-type migraine pain and protect dental structures from wear and damage. It is intended for over-the-counter use. The device is worn in the mouth during sleep; it functions mechanically to provide a splinting effect, reducing the force of jaw muscle contractions and minimizing the noise associated with grinding.

Indications for Use

Indicated for patients experiencing medically diagnosed migraine pain associated with jaw clenching and bruxing, and for patients requiring protection against bruxism or nighttime teeth grinding to reduce associated dental damage and noise.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Submission Summary (Full Text)

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September 17, 2021

Boyd Research, Inc. James Boyd, DDS, President 5820 Bali Way S St. Pete Beach, Florida 33706

Re: K211158

Trade/Device Name: NTI ClenchGuard Regulatory Class: Unclassified Product Code: OBR, MQC, OCO Dated: May 28, 2021 Received: June 2, 2021

Dear James Boyd:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

**K211158**

Device Name

## NTI ClenchGuard

Indications for Use (Describe)

1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing;

2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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