# K102053: Butler Calci-Flor Prophylaxis Paste

- Pathway: 510(k) (Traditional)
- Applicant: Sunstar Americas, Inc.
- Decided: Feb 3, 2011 after 196 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: 3 generations back to K925409 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952091: Vutler G.U.M. with Fluoride, John O. Butler Co. (1995) Summary page 1.
- K912945: Satin Prophylaxis Paste, Dentsply Intl. (1991) Summary page 1.
- K062166: Enamel Pro, Premier Dental Products Co. (2006) Summary page 1.

## Indications for use
Butler® Calci-Flor Prophylaxis Paste is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Source page: https://510kreport.com/device/K102053
Methodology: https://510kreport.com/methodology