# K233434: Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)

- Pathway: 510(k) (Special)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Nov 14, 2023 after 32 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: 4 generations back to K070327 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210694: Silent Nite Sleep Appliance with the Glidewell Hinge, Prismatik Dentalcraft, Inc. (2021) Summary page 5.

## Indications for use
Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. It 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/K233434
Methodology: https://510kreport.com/methodology