# K170578: True Function Adjustable Herbst Appliances

- Pathway: 510(k) (Abbreviated)
- Applicant: True Function Laboratory, Inc.
- Decided: Nov 24, 2017 after 270 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: 10 generations back to K882303 (1989). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113126: Acrylic Herbst Appliance, Gergens Orthodontic Lab (2013) Summary page 4.
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013) Summary page 4.
- K103076: Dynaflex, Dyna Flex (2011) Summary page 4.

## Indications for use
“The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions.”

Source page: https://510kreport.com/device/K170578
Methodology: https://510kreport.com/methodology