# K022900: Butler Gum Vari-Clean Power Toothbrushes

- Pathway: 510(k) (Traditional)
- Applicant: John O. Butler Co.
- Decided: Nov 14, 2002 after 72 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: 3 generations back to K950993 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020776: Medoral Hygienic Toothbrush with Dentosan Filaments, Coronet Group North America, LLC (2002) Summary page 2.

## Indications for use
Butler's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bristles (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles between uses.

Source page: https://510kreport.com/device/K022900
Methodology: https://510kreport.com/methodology