# K192581: The NightBlocks Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Facialdontics, LLC
- Decided: Jan 28, 2020 after 131 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: 9 generations back to K882303 (1989). 17 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013) Summary page 4.

## Most influential descendants
- K191320: Slow Wave DS8 (2020), 5 descendants of its own
- K233754: AIO Breathe (2024), 1 descendant of its own
- K230532: RADx Intraoral Appliance for Snoring and Sleep Apnea (2023), 1 descendant of its own
- K254304: iNOS intraoral biosensor (2026), 0 descendants of its own
- K252525: AIO Breathe (2025), 0 descendants of its own

## Indications for use
The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is 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/K192581
Methodology: https://510kreport.com/methodology