# K230495: Serena Sleep Night Guard

- Pathway: 510(k) (Traditional)
- Applicant: Meris Investment Group
- Decided: Oct 13, 2023 after 232 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: 7 generations back to K882303 (1989). 21 ancestors in all.
1 later device descends 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)
- K203596: Panthera Occlusal Appliance, Panthera Dental, Inc. (2021) Summary page 5.

## Most influential descendants
- K230548: Myoaligner Appliance (2024), 0 descendants of its own

## Indications for use
The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient’s mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.

Source page: https://510kreport.com/device/K230495
Methodology: https://510kreport.com/methodology