# K971025: Ayurvedic Tongue Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Calello Martinez P.C.
- Decided: May 22, 1997 after 63 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ayurvedic Tongue Cleaner is a device used to remove. food parti¢les and debris from the tongque. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.

Source page: https://510kreport.com/device/K971025
Methodology: https://510kreport.com/methodology