# K130186: Dentek Easy Brush with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Jul 15, 2013 after 171 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 K925409 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942633: Oral-B Interdental Woodsticks with Fluoride, Oral-B Laboratories (1995) Summary page 1.
- K935440: Johnson & Johnson Fluoride Dental Floss, Mint Waxed, Johnson & Johnson Consumer Products, Inc. (1994) Summary page 1.

## Indications for use
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean interdental spaces, as it is done with dental floss.

Source page: https://510kreport.com/device/K130186
Methodology: https://510kreport.com/methodology