# K992270: Miraclebreath Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Stellar Labs, Inc.
- Decided: Sep 23, 1999 after 79 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: 3 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)
- 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.
- K983683: Unik Tongue Cleaner, Unik Products, Inc. (1999) Summary page 1.

## Indications for use
To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.

Source page: https://510kreport.com/device/K992270
Methodology: https://510kreport.com/methodology