BPA-FREE PIT AND FISSURE SEALANT— 510(k) K110058

Name: FDA 510(k) clearance K110058
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Substantially Equivalent

Novocol Inc. Dba Septodont and Confi-Dental Produc

FDA 510(k) clearance K110058 for BPA-FREE PIT AND FISSURE SEALANT, Substantially Equivalent on 2011-03-31. 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 EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 2011-01-10
Decision date: 2011-03-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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