# K143623: Narval Brux

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Sas
- Decided: Aug 13, 2015 after 234 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: 3 generations back to K981546 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102909: Somnobrux Splints, Somnomed, Inc. (2011) Summary page 4.

## Indications for use
The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.

Source page: https://510kreport.com/device/K143623
Methodology: https://510kreport.com/methodology