# K042048: Gelato Prophylaxis Paste

- Pathway: 510(k) (Traditional)
- Applicant: Deepak Products, Inc.
- Decided: Oct 26, 2004 after 88 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
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. NOTE: Prophylasis pastes containing fluoride are not considered a replacement for other forms of fluoride therapy. Gelato dental prophylaxis paste with fluoride contains a unique blend of polishing and cleaning agents. Dental Prophylaxis Paste is for professional use only and is designed for application during standard dental practice hygiene procedures. This product contains fluoride at a concentration of 1.23% fluoride ion.

Source page: https://510kreport.com/device/K042048
Methodology: https://510kreport.com/methodology