OPTIFLOW II FLOWABLE COMPOSITE, LC— 510(k) K130672

Name: FDA 510(k) clearance K130672
Creator: U.S. Food and Drug Administration
Published: 2013-08-13

Substantially Equivalent

Pac-Dent International, Inc.

FDA 510(k) clearance K130672 for OPTIFLOW II FLOWABLE COMPOSITE, LC, Substantially Equivalent on 2013-08-13. Applicant: Pac-Dent International, Inc.. Device class: 2.

Clearance details

Applicant: Pac-Dent International, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2013-03-12
Decision date: 2013-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut, CA, US

Download summary PDF View on FDA.gov ↗

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