# K973175: Tongue Klean

- Pathway: 510(k) (Traditional)
- Applicant: Softek Ent.
- Decided: Oct 14, 1997 after 50 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: 1 generation back to K962941 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962941: Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High & Low Ripple/Comfort Eze, Deep Trading Corp. (1996) Summary page 1.

## Most influential descendants
- K990344: Oralgiene Tongue Cleaner (1999), 0 descendants of its own

## Indications for use
Tongue Klean is indicated for use as part of the daily oral hygiene to remove plaque from the surface of the tongue.

Source page: https://510kreport.com/device/K973175
Methodology: https://510kreport.com/methodology