# K983683: Unik Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Unik Products, Inc.
- Decided: Jan 14, 1999 after 86 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K992270: Miraclebreath Tongue Cleaner (1999), 0 descendants of its own

## Indications for use
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plague build-up on the tongue to help fight bad breath and promote oral hygiene.

Source page: https://510kreport.com/device/K983683
Methodology: https://510kreport.com/methodology