# K193577: SleepRight ProRx Custom Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Splintek, Inc.
- Decided: Jun 1, 2020 after 161 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- 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: 4 generations back to K022809 (2003). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172223: SleepRight ProRx Custom Dental Guard, Splintek, Inc. (2017) Summary page 5.
- K121272: Protech Dent, Akervall Technologies, Inc. (2012) Summary page 5.

## Most influential descendants
- K250743: Remvia NightGuard (2025), 0 descendants of its own
- K212706: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (2021), 0 descendants of its own

## Indications for use
Protection against bruxism or nighttime teeth grinding Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding 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/K193577
Methodology: https://510kreport.com/methodology