# K971589: Reach Antibacterial Toothbrush

- Pathway: 510(k) (Traditional)
- Applicant: Personal Products Co.
- Decided: Jul 24, 1997 after 84 days
- Product code: EFW (Toothbrush, Manual)
- 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: 1 generation back to K950993 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950993: Butler G.U.M. Antibacterial Toothbrush, John O. Butler (1995) Summary page 1.

## Most influential descendants
- K020776: Medoral Hygienic Toothbrush with Dentosan Filaments (2002), 1 descendant of its own
- K022900: Butler Gum Vari-Clean Power Toothbrushes (2002), 0 descendants of its own

## Indications for use
REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush,

Source page: https://510kreport.com/device/K971589
Methodology: https://510kreport.com/methodology