# K211069: EndSnorZ Sleep Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Oct 26, 2021 after 197 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K070327 (2007). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183270: Silent Nite sl, Prismatik Dentalcraft, Inc. (2019) Summary page 4.

## Most influential descendants
- K240427: airVata™ (2024), 0 descendants of its own

## Indications for use
EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Source page: https://510kreport.com/device/K211069
Methodology: https://510kreport.com/methodology