# K223624: Emerald Herbst

- Pathway: 510(k) (Traditional)
- Applicant: Island Dental Lab, Inc Dba Emerald Dental
- Decided: May 10, 2023 after 156 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170692: Respire Pink Series with DentiTrac, Respire Medical Holding (2017) Summary page 4.
- K131138: Respire Pink Series - Herbst, Respire Medical (2013) Summary page 4.
- K150572: Respire Pink Series-Herbst-EF, Respire Medical Holding (2015) Summary page 4.

## Indications for use
The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.

Source page: https://510kreport.com/device/K223624
Methodology: https://510kreport.com/methodology