# K130130: Atg/SM-Osa Appliances

- Pathway: 510(k) (Traditional)
- Applicant: Selane Products, Inc.
- Decided: Aug 26, 2013 after 221 days
- Product code: LQZ (Device, Jaw Repositioning)
- 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: 8 generations back to K882303 (1989). 16 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103076: Dynaflex, Dyna Flex (2011) Summary page 1.

## Most influential descendants
- K192581: The NightBlocks Appliance (2020), 6 descendants of its own
- K191320: Slow Wave DS8 (2020), 5 descendants of its own
- K130067: Mrna Appliance (2014), 5 descendants of its own
- K222872: DNA Appliance (2022), 2 descendants of its own
- K233754: AIO Breathe (2024), 1 descendant of its own

## Indications for use
The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Source page: https://510kreport.com/device/K130130
Methodology: https://510kreport.com/methodology