# K181099: Bright Guard

- Pathway: 510(k) (Traditional)
- Applicant: Koncept Innovators, LLC
- Decided: Jan 18, 2019 after 267 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: 7 generations back to K882303 (1989). 18 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133037: Grindguard, Grind Guard Technologies, LLC (2014) Summary page 4.

## Most influential descendants
- K221369: FBCC Night Guard (2022), 3 descendants of its own
- 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
- K240810: Anti Grinding Guard (2024), 0 descendants of its own

## Indications for use
Bright Guard is a mouth guard intended to protect against grinding and clenching.

Source page: https://510kreport.com/device/K181099
Methodology: https://510kreport.com/methodology