# K250743: Remvia NightGuard

- Pathway: 510(k) (Traditional)
- Applicant: Remvia
- Decided: Dec 5, 2025 after 269 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: 5 generations back to K022809 (2003). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193577: SleepRight ProRx Custom Dental Guard, Splintek, Inc. (2020) Summary page 5.

## Indications for use
The Remvia NightGuard is indicated for: • Protection against teeth grinding, bruxism, and jaw clenching • Short-term pain relief from muscle spasm due to occlusal interference • Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

Source page: https://510kreport.com/device/K250743
Methodology: https://510kreport.com/methodology