# K181123: ApnoDent Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Apnomed, Inc.
- Decided: Nov 21, 2018 after 205 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)
- K130067: Mrna Appliance, Biomodeling Solutions, Lls (2014) Summary page 4.

## Indications for use
The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.

Source page: https://510kreport.com/device/K181123
Methodology: https://510kreport.com/methodology