# K100545: Sleepright

- Pathway: 510(k) (Traditional)
- Applicant: Power Products, Inc.-Splintek
- Decided: Jun 4, 2010 after 98 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: 1 generation back to K071404 (2007). 1 ancestor in all.
30 later devices descend from it; 2 cite it directly.
0 of 32 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 2.

## Most influential descendants
- 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
- K113569: Apnearx (2012), 4 descendants of its own

## Indications for use
The SleepRight Original 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/K100545
Methodology: https://510kreport.com/methodology