# K211158: NTI ClenchGuard

- Pathway: 510(k) (Traditional)
- Applicant: Boyd Research, Inc.
- Decided: Sep 17, 2021 after 151 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K251778: Remi Custom Night Guard (2025), 1 descendant of its own
- K253641: Owl Night Guard (2026), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K211158
Methodology: https://510kreport.com/methodology