# K040988: Zircon-F Prophylaxis Paste

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Co., Inc.
- Decided: Jul 7, 2004 after 83 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: 2 generations back to K002989 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033449: Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices, Professional Dental Technologies Therapeutics, Inc. (2004) Summary page 1.
- K024343: Butler Gum Prophy Paste with Novamin, Usbiomaterials Corp. (2003) Summary page 1.
- K000169: Nupro Prophylaxis Paste with Fluoride and Triclosan, Dentsply Intl. (2000) Summary page 1.

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

Source page: https://510kreport.com/device/K040988
Methodology: https://510kreport.com/methodology