EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC— 510(k) K103699

Name: FDA 510(k) clearance K103699
Creator: U.S. Food and Drug Administration
Published: 2011-08-12

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K103699 for EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC, Substantially Equivalent on 2011-08-12. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code NUN
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-12-20
Decision date: 2011-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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