# K990344: Oralgiene Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Oralgiene USA, Inc.
- Decided: May 4, 1999 after 89 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 K961660 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973175: Tongue Klean, Softek Ent. (1997) Summary page 1.
- K972644: Breath-SO-Fresh Tongue Cleaner, Intl. Dental Design Specialists, Inc. (1997) Summary page 1.

## Indications for use
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.

Source page: https://510kreport.com/device/K990344
Methodology: https://510kreport.com/methodology