# K172223: SleepRight ProRx Custom Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Splintek, Inc.
- Decided: Nov 17, 2017 after 116 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: 3 generations back to K022809 (2003). 8 ancestors in all.
3 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)
- K121272: Protech Dent, Akervall Technologies, Inc. (2012) Summary page 5.
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 5.

## Most influential descendants
- K193577: SleepRight ProRx Custom Dental Guard (2020), 2 descendants of its own
- 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
The SleepRight® ProRx® Custom Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to 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. For the 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/K172223
Methodology: https://510kreport.com/methodology