CARBOXYLATE CEM, PHOSPHATE CEM— 510(k) K081702

Name: FDA 510(k) clearance K081702
Creator: U.S. Food and Drug Administration
Published: 2008-09-05

Substantially Equivalent

S & C Polymer GmbH

FDA 510(k) clearance K081702 for CARBOXYLATE CEM, PHOSPHATE CEM, Substantially Equivalent on 2008-09-05. Applicant: S & C Polymer GmbH. Device class: 2.

Clearance details

Applicant: S & C Polymer GmbH
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2008-06-17
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elmshorn, DE

Download summary PDF View on FDA.gov ↗

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