GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE— 510(k) K101540

Name: FDA 510(k) clearance K101540
Creator: U.S. Food and Drug Administration
Published: 2010-10-29

Substantially Equivalent

Novocol Inc. Dba Septodont and Confi-Dental Produc

FDA 510(k) clearance K101540 for GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE, Substantially Equivalent on 2010-10-29. Applicant: Novocol Inc. Dba Septodont and Confi-Dental Produc. Device class: 2.

Clearance details

Applicant: Novocol Inc. Dba Septodont and Confi-Dental Produc
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2010-06-03
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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