BUTLER CALCI-FLOR PROPHYLAXIS PASTE— 510(k) K102053

Name: FDA 510(k) clearance K102053
Creator: U.S. Food and Drug Administration
Published: 2011-02-03

Substantially Equivalent

Sunstar Americas, Inc.

FDA 510(k) clearance K102053 for BUTLER CALCI-FLOR PROPHYLAXIS PASTE, Substantially Equivalent on 2011-02-03. Applicant: Sunstar Americas, Inc.. Device class: 1.

Clearance details

Applicant: Sunstar Americas, Inc.
Product code: Code EJR
Device class: Class 1
Regulation: 21 CFR 872.6030
Advisory panel: Dental
Date received: 2010-07-22
Decision date: 2011-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Bluff, IL, US

Download summary PDF View on FDA.gov ↗

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