# K253641: Owl Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: Owl Dental Lab, Inc.
- Decided: Feb 26, 2026 after 99 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
Longest line of descent: 10 generations back to K882303 (1989). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251778: Remi Custom Night Guard, Remi (2025) Summary page 5.
- K211158: NTI ClenchGuard, Boyd Research, Inc. (2021) Summary page 5.

## Indications for use
The Owl Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.

Source page: https://510kreport.com/device/K253641
Methodology: https://510kreport.com/methodology