# K230548: Myoaligner Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Myohealth Technologies, LLC
- Decided: Feb 2, 2024 after 339 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: 8 generations back to K882303 (1989). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 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 5.
- K102909: Somnobrux Splints, Somnomed, Inc. (2011) Summary page 5.
- K230495: Serena Sleep Night Guard, Meris Investment Group (2023). Cleared while this submission was under review Summary page 5.

## Indications for use
For protection against teeth grinding, bruxism, and jaw clenching; protection of restorations from injury due to bruxism or clenching; relief of bruxism related headaches, migraines and pain; short-term relief from muscle spasm due to occlusal interference; prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles; and temporary treatment of temporal mandibular disorder (TMD) along with the relief of associated headaches and pains in adults 18 years of age or older.

Source page: https://510kreport.com/device/K230548
Methodology: https://510kreport.com/methodology