# K212706: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Splintek, Inc.
- Decided: Dec 13, 2021 after 109 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: 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 7.
- K172223: SleepRight ProRx Custom Dental Guard, Splintek, Inc. (2017) Summary page 7.

## 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 * 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/K212706
Methodology: https://510kreport.com/methodology