# K181005: ClenchGuard

- Pathway: 510(k) (Traditional)
- Applicant: Boyd Research, Inc.
- Decided: Jan 15, 2020 after 639 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- Device class: U
- 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
For the temporary prevention of migraine and pain associated with bruxism. For the protection against jaw clenching and teeth grinding. - Protection against bruxism or nighttime teeth grinding. - Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.

Source page: https://510kreport.com/device/K181005
Methodology: https://510kreport.com/methodology