Cleared Traditional

BUTLER CALCI-FLOR PROPHYLAXIS PASTE

K102053 · Sunstar Americas, Inc. · Dental

Feb 2011

Decision

196d

Days

Class 1

Risk

About This 510(k) Submission

K102053 is an FDA 510(k) clearance for the BUTLER CALCI-FLOR PROPHYLAXIS PASTE, a Agent, Polishing, Abrasive, Oral Cavity (Class I — General Controls, product code EJR), submitted by Sunstar Americas, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on February 3, 2011, 196 days after receiving the submission on July 22, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6030.

Submission Details

510(k) Number	K102053 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2010
Decision Date	February 03, 2011
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF