# K973424: Enfresh Tongue Brush

- Pathway: 510(k) (Traditional)
- Applicant: Enfresh Products, LLC
- Decided: Dec 9, 1997 after 90 days
- Product code: LCN (Scraper, Tongue)
- Device class: 1
- Regulation: 21 CFR 872.6855
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961574 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901408: The Tongue Brush, Garry Laboratories, Inc. (1990) Summary page 1.
- K970042: Ooli-U (Tongue Scraper), Telefax Intl. (1997) Summary page 1.

## Indications for use
To remove plaque and food debris from the surface of the tongue.

Source page: https://510kreport.com/device/K973424
Methodology: https://510kreport.com/methodology