# K083209: Acrylic Herbst Splint Appliance

- Pathway: 510(k) (Abbreviated)
- Applicant: Specialty Appliance Works, Inc.
- Decided: Jan 27, 2009 after 88 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: 1 generation back to K070327 (2007). 1 ancestor in all.
38 later devices descend from it; 7 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070327: Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator, Sybron Dental Specialties, Inc. (2007) Summary page 1.

## Most influential descendants
- K103076: Dynaflex (2011), 29 descendants of its own
- K130130: Atg/SM-Osa Appliances (2013), 17 descendants of its own
- K160234: OVENT (2016), 8 descendants of its own
- K161832: O2VENT T (2016), 7 descendants of its own
- K192581: The NightBlocks Appliance (2020), 6 descendants of its own

## Indications for use
The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Source page: https://510kreport.com/device/K083209
Methodology: https://510kreport.com/methodology