# K151933: BRX PRO Bruxism Guard

- Pathway: 510(k) (Traditional)
- Applicant: 12th Man Technologies, Inc.
- Decided: Dec 10, 2015 after 149 days
- Product code: MQC (Mouthguard, Prescription)
- 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: 6 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)
- K123161: Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard Elite, Smartguard, Inc. (2013) Summary page 4.
- K111066: Migra Tab, Quicksplint Migraine, Migratherapy, LLC (2011) Summary page 4.

## Indications for use
The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.

Source page: https://510kreport.com/device/K151933
Methodology: https://510kreport.com/methodology