# K070127: Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02

- Pathway: 510(k) (Traditional)
- Applicant: Kevin Vu, Dds
- Decided: Mar 29, 2007 after 72 days
- Product code: EMN (Scaler, Periodontic)
- Device class: 1
- Regulation: 21 CFR 872.4565
- 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 K963747 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963747: Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with Microdent/Reach Floss Pics with Microdent Etc., Whitehill Manufacturing, Inc. (1996) Summary page 2.

## Indications for use
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device which removes plaque and food between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.

Source page: https://510kreport.com/device/K070127
Methodology: https://510kreport.com/methodology