# K974160: Bruxtrak Material

- Pathway: 510(k) (Traditional)
- Applicant: Bruxcare, LLC
- Decided: Mar 11, 1998 after 126 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

Source page: https://510kreport.com/device/K974160
Methodology: https://510kreport.com/methodology