# K262559: Mouth Guard

- Pathway: 510(k) (Traditional)
- Applicant: ChangSha ChuangDuoLe E-Commerce Co., Ltd.
- Decided: Sep 16, 2026 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Source page: https://510kreport.com/device/K262559
Methodology: https://510kreport.com/methodology