# K040315: Myohealth Clenching Inhibitor

- Pathway: 510(k) (Traditional)
- Applicant: Mci-Myohealth Systems
- Decided: Aug 27, 2004 after 200 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: 1 generation back to K981546 (1998). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981546: Nti Clenching Suppression System, Heraeus Kulzer, Inc. (1998) Summary page 2.

## Most influential descendants
- K111066: Migra Tab, Quicksplint Migraine (2011), 7 descendants of its own
- K170985: Urbanek Device (2017), 4 descendants of its own
- K102909: Somnobrux Splints (2011), 4 descendants of its own
- K182820: The POD (2019), 3 descendants of its own
- K203596: Panthera Occlusal Appliance (2021), 2 descendants of its own

## Indications for use
1. Protection of teeth and restorations from the forces of bruxism. 2. For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.

Source page: https://510kreport.com/device/K040315
Methodology: https://510kreport.com/methodology