# K980075: Cybersonic

- Pathway: 510(k) (Traditional)
- Applicant: American Dentronics, Inc.
- Decided: Mar 4, 1998 after 55 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K181986: Klinly Ultrasonic Tongue Cleaner (2019), 0 descendants of its own

## Indications for use
Use to remove surface tongue debris, residue, plagque or filmy build-up that result fram eating, drinking, smoking or other types of consumption which can lead to bad hreath. Also may be used to remove salivary tongue plaques and residue that naturally accumulatée during sleep or between cleanings

Source page: https://510kreport.com/device/K980075
Methodology: https://510kreport.com/methodology