# K181416: Sapphire Dorsal Comfort Fit

- Pathway: 510(k) (Traditional)
- Applicant: Crane Dental Laboratory, Inc.
- Decided: Sep 17, 2019 after 474 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: 5 generations back to K882303 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073004: Somnomed  Bflex, Somnomed, Inc. (2008) Summary page 5.

## Indications for use
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.

Source page: https://510kreport.com/device/K181416
Methodology: https://510kreport.com/methodology