# K212767: SleepRight Select-Comfort Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Splintek, Inc.
- Decided: Dec 22, 2021 after 113 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: 2 generations back to K071404 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071404: Sleep Right - Select, Low Profile and Advance, Power Products, Inc.-Splintek (2007) Summary page 5.
- K100545: Sleepright, Power Products, Inc.-Splintek (2010) Summary page 5.

## Indications for use
The SleepRight@ Select-Comfortm 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. The SleepRight@ Select-Comfortm Dental Guard is indicated for the 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/K212767
Methodology: https://510kreport.com/methodology