# K033785: Proactive Care Prophylaxis Paste with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, Inc.
- Decided: Jun 18, 2004 after 197 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 K990482 (1999). 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)
- K000169: Nupro Prophylaxis Paste with Fluoride and Triclosan, Dentsply Intl. (2000) Summary page 2.
- K002989: Proclude, Ortek Therapeutics, Inc. (2000) Summary page 2.
- K990482: 3M Clinpro Prophy Paste, Model 12611, Minnesota Mining and Mfg. Co. (1999) Summary page 2.

## Indications for use
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.

Source page: https://510kreport.com/device/K033785
Methodology: https://510kreport.com/methodology