# K071404: Sleep Right - Select, Low Profile and Advance

- Pathway: 510(k) (Traditional)
- Applicant: Power Products, Inc.-Splintek
- Decided: Aug 17, 2007 after 88 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
No predicates in its family tree.
52 later devices descend from it; 9 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EZ Splint: named in the summary without a submission number
- (no number) The Doctor's® NightGuard: named in the summary without a submission number

## Most influential descendants
- K100545: Sleepright (2010), 30 descendants of its own
- K103004: Snore Guard (2011), 28 descendants of its own
- K112205: Snorerx 9.0 (2011), 26 descendants of its own
- K153200: SnoreRx (2016), 22 descendants of its own
- K170825: SnoreRx (2017), 21 descendants of its own

## Indications for use
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. The SleepRight® adjustable night 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.

Source page: https://510kreport.com/device/K071404
Methodology: https://510kreport.com/methodology