# K203596: Panthera Occlusal Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Panthera Dental, Inc.
- Decided: Apr 20, 2021 after 132 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). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182820: The POD, Advanced Facialdontics, LLC (2019) Summary page 4.
- K102909: Somnobrux Splints, Somnomed, Inc. (2011) Summary page 4.
- K143244: The Panthera Anti-Snoring Device, Panthera Dental, Inc. (2014) Summary page 4.

## Most influential descendants
- K230495: Serena Sleep Night Guard (2023), 1 descendant of its own
- K230548: Myoaligner Appliance (2024), 0 descendants of its own

## Indications for use
The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.

Source page: https://510kreport.com/device/K203596
Methodology: https://510kreport.com/methodology