# K970042: Ooli-U (Tongue Scraper)

- Pathway: 510(k) (Traditional)
- Applicant: Telefax Intl.
- Decided: Mar 14, 1997 after 67 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 K961574 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961574: Tongue Scrapper, U.S. Dentek Corp. (1996) Summary page 1.

## Most influential descendants
- K980842: Copper Tongue Scraper (1998), 0 descendants of its own
- K973424: Enfresh Tongue Brush (1997), 0 descendants of its own

## Indications for use
The device is intended to remove plaque and food debris from the surface of the tongue.

Source page: https://510kreport.com/device/K970042
Methodology: https://510kreport.com/methodology