# K111310: Brux Mouthguards

- Pathway: 510(k) (Traditional)
- Applicant: Dental Arte, Inc.
- Decided: Dec 8, 2011 after 212 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: 2 generations back to K053580 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073446: Grind Guard, Archtek, Inc. (2008) Summary page 1.

## Indications for use
BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.

Source page: https://510kreport.com/device/K111310
Methodology: https://510kreport.com/methodology