# K972644: Breath-SO-Fresh Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Dental Design Specialists, Inc.
- Decided: Sep 11, 1997 after 58 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 K961660 (1996). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961660: Tongue Cleaner, Jack Conrey (1996) Summary page 1.
- 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
- K983683: Unik Tongue Cleaner (1999), 1 descendant of its own
- K992270: Miraclebreath Tongue Cleaner (1999), 0 descendants of its own
- K990344: Oralgiene Tongue Cleaner (1999), 0 descendants of its own

## 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/K972644
Methodology: https://510kreport.com/methodology