# K183270: Silent Nite sl

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jul 17, 2019 after 236 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070327 (2007). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083209: Acrylic Herbst Splint Appliance, Specialty Appliance Works, Inc. (2009) Summary page 5.
- (no number) SilentNite: named in the summary without a submission number

## Most influential descendants
- K211069: EndSnorZ Sleep Appliance (2021), 1 descendant of its own
- K210694: Silent Nite Sleep Appliance with the Glidewell Hinge (2021), 1 descendant of its own
- K240427: airVata™ (2024), 0 descendants of its own
- K233434: Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) (2023), 0 descendants of its own

## Recalls of this device
- Apr 27, 2026 · Class II · Z-2769-2026: Due to device not having FDA Clearance

## Indications for use
Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl 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/K183270
Methodology: https://510kreport.com/methodology