# K070327: Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: May 25, 2007 after 109 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.
43 later devices descend from it; 5 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) State University of New York at Buffalo, School of Dental Medicine, Removable Herbst Appliance: named in the summary without a submission number
- (no number) Hays & Meade Inc., Snore Guard: named in the summary without a submission number
- (no number) Great Lakes Orthodontic Laboratory, NAPA Appliance: named in the summary without a submission number

## Most influential descendants
- K083209: Acrylic Herbst Splint Appliance (2009), 38 descendants of its own
- 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

## Indications for use
The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw. The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw. The Enoch Snorinator is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.

Source page: https://510kreport.com/device/K070327
Methodology: https://510kreport.com/methodology