# K980842: Copper Tongue Scraper

- Pathway: 510(k) (Traditional)
- Applicant: Ontel Products Corp.
- Decided: May 20, 1998 after 77 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 K961574 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K970042: Ooli-U (Tongue Scraper), Telefax Intl. (1997) Summary page 1.

## Indications for use
Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.

Source page: https://510kreport.com/device/K980842
Methodology: https://510kreport.com/methodology