# K012914: Sonicwave Sonic Plaque Remover

- Pathway: 510(k) (Traditional)
- Applicant: Homedics, Inc.
- Decided: Oct 1, 2001 after 32 days
- Product code: JEQ (Toothbrush, Powered)
- Device class: 1
- Regulation: 21 CFR 872.6865
- 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 K921773 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921773: TX Electric Toothbrush, Optiva Corp. (1992) Summary page 1.

## Indications for use
Operates at over 30,000 strokes per minute to help remove plaque bacteria Sonic waves penetrate beyond the bristle tips, for superior cleaning. Ergonomic design with rubberized Comfort-Grip surface. Two-minute timer helps ensure dentist recommended brush time.

Source page: https://510kreport.com/device/K012914
Methodology: https://510kreport.com/methodology