# K021569: Restful Nights, Ist-Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Ottawa Dental Laboratory
- Decided: Mar 15, 2004 after 671 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The I ST'm - Appliance Intraoral Snoring-Therapy Appliance is designed for the treatment of snoring and mild obstructive sleep apnea.

Source page: https://510kreport.com/device/K021569
Methodology: https://510kreport.com/methodology