# K102909: Somnobrux Splints

- Pathway: 510(k) (Traditional)
- Applicant: Somnomed, Inc.
- Decided: Dec 13, 2011 after 438 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: 2 generations back to K981546 (1998). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040315: Myohealth Clenching Inhibitor, Mci-Myohealth Systems (2004) Summary page 1.
- K022627: DSG Relaxer Splint, Sentage Corporation D/B/A/ Dental Services Group (2003) Summary page 1.

## Most influential descendants
- K203596: Panthera Occlusal Appliance (2021), 2 descendants of its own
- K230495: Serena Sleep Night Guard (2023), 1 descendant of its own
- K230548: Myoaligner Appliance (2024), 0 descendants of its own
- K143623: Narval Brux (2015), 0 descendants of its own

## Indications for use
The SomnoBrux Splints are Used for the protection of teeth and restorations from the forces of Bruxism.

Source page: https://510kreport.com/device/K102909
Methodology: https://510kreport.com/methodology