# K143591: Dorsal Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Gergens Orthodontic Lab
- Decided: Apr 15, 2015 after 118 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: 10 generations back to K882303 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113126: Acrylic Herbst Appliance, Gergens Orthodontic Lab (2013) Summary page 4.

## Indications for use
The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Source page: https://510kreport.com/device/K143591
Methodology: https://510kreport.com/methodology