# K170606: Acrylic Herbst Appliance with Micro-Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Gergen'S Orthodontic Lab
- Decided: Nov 16, 2017 after 260 days
- Product code: PLC (Sleep Appliances With Patient Monitoring)
- 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150369: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder, Somnomed, Inc. (2015) Summary page 5.

## 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. When a DentiTrac® micro-recorder is embedded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

Source page: https://510kreport.com/device/K170606
Methodology: https://510kreport.com/methodology