BRUXTRAK MATERIAL

K974160 · Bruxcare, LLC · EBI · Mar 11, 1998 · Dental

Device Facts

• Record ID: K974160
• Device Name: BRUXTRAK MATERIAL
• Applicant: Bruxcare, LLC
• Product Code: EBI · Dental
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Brux Trak™ material is intended for construction of temporary occlusal splints. When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following: - 1. Temporarily protect the teeth or dental work from damage due to teeth grinding - 2. Promote patient awareness of oro-myofacial habits, such as bruxism. - 3. Aid the dentist in locating occlusal areas of current wear - 4. Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits - 5. Aid the dentist in differentiating between historical tooth wear and current grinding activity. .. - 6. Provide a physical record of a patient's grinding activity for a certain time period.

Device Story

BruxTrak™ is a dental material used to construct temporary occlusal splints. Formed by a licensed dentist or lab technician, the splint is worn by the patient to protect teeth from damage caused by bruxism. The material functions as a diagnostic aid, allowing the dentist to observe occlusal wear patterns, differentiate between historical and active grinding, and quantify the severity of grinding habits over a specific period. The device provides a physical record of patient activity, which the dentist uses to inform clinical treatment decisions and patient counseling regarding oro-myofacial habits.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental material for occlusal splint fabrication. Class II device (Product Code EBI).

Indications for Use

Indicated for patients requiring temporary occlusal splints to protect teeth/dental work from bruxism, promote awareness of oro-myofacial habits, and assist dentists in evaluating, measuring, and recording grinding activity. Prescription use only.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved lines that resemble a person with outstretched arms, symbolizing health and well-being. The overall design is simple and recognizable, representing the department's role in promoting public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Justus Baird ·Product Manager BruxCare, L.L.C. 6331 Pineshade Lane Houston, Texas 77008

MAR 1 1 1998

Re : K974160 BruxTrak™ Trade Name: Regulatory Class: II Product Code: EBI Dated: February 13, 1998 Received: February 24, 1998

Dear Mr. Baird:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes-compliance with =============================================================================================================== the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Baird

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timc Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ***_ of _***

| 510(k) Number (if known): | K974160 |
|---------------------------|---------------------|
| Device Name: | Brux Tsak™ material |

Indications For Use:

Brux Trak™ material is intended for construction of temporary occlusal splints.

When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following:

- 1. Temporarily protect the teeth or dental work from damage due to teeth grinding
- 2. Promote patient awareness of oro-myofacial habits, such as bruxism.
- 3. Aid the dentist in locating occlusal areas of current wear
- 4. Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits
- 5. Aid the dentist in differentiating between historical tooth wear and current grinding activity. ..
- 6. Provide a physical record of a patient's grinding activity for a certain time period.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Dental. Infe and General Hospita 510/k) Number

Prescription Use મ ડ્ (Per 21 CFR 801.109)

OR

Over-The-Counter Use \$\mathcal{N}^D\$

(Optional Format 1-2-96)