# K221369: FBCC Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: Fbcc, Inc.
- Decided: Nov 18, 2022 after 190 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: 8 generations back to K882303 (1989). 19 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K181099: Bright Guard, Koncept Innovators, LLC (2019) Summary page 6.

## Most influential descendants
- K251778: Remi Custom Night Guard (2025), 1 descendant of its own
- K253641: Owl Night Guard (2026), 0 descendants of its own
- K252004: enCore Night Guard (2025), 0 descendants of its own

## Indications for use
The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

Source page: https://510kreport.com/device/K221369
Methodology: https://510kreport.com/methodology