# K020776: Medoral Hygienic Toothbrush with Dentosan Filaments

- Pathway: 510(k) (Traditional)
- Applicant: Coronet Group North America, LLC
- Decided: Jun 3, 2002 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: 2 generations back to K950993 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971589: Reach Antibacterial Toothbrush, Personal Products Co. (1997) Summary page 1.
- K973236: Crest Toothbrush with Microshield, Procter & Gamble Co. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K974761: Butler Antibacterial Interdental Toothbrush, John O. Butler Co. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K022900: Butler Gum Vari-Clean Power Toothbrushes (2002), 0 descendants of its own

## Indications for use
The Medoral Hygienic Toothbrush with DENTOSANB Filaments is a toothbrush to remove plaque and debris fkom the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.

Source page: https://510kreport.com/device/K020776
Methodology: https://510kreport.com/methodology