# K251778: Remi Custom Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: Remi
- Decided: Oct 17, 2025 after 129 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: 9 generations back to K882303 (1989). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221369: FBCC Night Guard, Fbcc, Inc. (2022) Summary page 5.
- K211158: NTI ClenchGuard, Boyd Research, Inc. (2021) Summary page 5.

## Most influential descendants
- K253641: Owl Night Guard (2026), 0 descendants of its own

## Indications for use
The Remi Custom 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/K251778
Methodology: https://510kreport.com/methodology