# K962370: Perfect Choice Prophy Paste with 10% Carbamide Peroxide

- Pathway: 510(k) (Traditional)
- Applicant: Challenge Products, Inc.
- Decided: Mar 31, 1997 after 285 days
- Product code: EJR (Agent, Polishing, Abrasive, Oral Cavity)
- Device class: 1
- Regulation: 21 CFR 872.6030
- 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 K940496 (1994). 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)
- K940496: Prophy Paste, Challenge Products, Inc. (1994) Summary page 1.

## Indications for use
The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

Source page: https://510kreport.com/device/K962370
Methodology: https://510kreport.com/methodology