# K040661: Radent Prophy Paste

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Co., Inc.
- Decided: Jun 9, 2004 after 89 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
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
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Source page: https://510kreport.com/device/K040661
Methodology: https://510kreport.com/methodology