# K113126: Acrylic Herbst Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Gergens Orthodontic Lab
- Decided: Jul 17, 2013 after 632 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: 9 generations back to K882303 (1989). 17 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 20 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.
- K083209: Acrylic Herbst Splint Appliance, Specialty Appliance Works, Inc. (2009) Summary page 1.
- K103076: Dynaflex, Dyna Flex (2011) Summary page 1.
- K111009: Acrylic Herbst Appliance, Embassy Dental Laboratory (2011) Summary page 1.

## Most influential descendants
- K170578: True Function Adjustable Herbst Appliances (2017), 0 descendants of its own
- K143591: Dorsal Appliance (2015), 0 descendants of its own

## Indications for use
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Source page: https://510kreport.com/device/K113126
Methodology: https://510kreport.com/methodology