# K240810: Anti Grinding Guard

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Yizhou Imp. & Exp. Co., Ltd.
- Decided: May 24, 2024 after 60 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.
No later device cites it as a predicate yet.
0 of 20 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 5.

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

Source page: https://510kreport.com/device/K240810
Methodology: https://510kreport.com/methodology