# K980995: Plaq-Ataq-I

- Pathway: 510(k) (Traditional)
- Applicant: Ethicare
- Decided: Aug 20, 1998 after 174 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC.) 2) OVER THE COUNTER DENTIFRICE. 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLO MODELS) . 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.

Source page: https://510kreport.com/device/K980995
Methodology: https://510kreport.com/methodology