ORTHODONTIC FLOWABLE BRACKET ADHESIVE— 510(k) K120619

Name: FDA 510(k) clearance K120619
Creator: U.S. Food and Drug Administration
Published: 2012-05-21

Substantially Equivalent

Novocol, Inc.

FDA 510(k) clearance K120619 for ORTHODONTIC FLOWABLE BRACKET ADHESIVE, Substantially Equivalent on 2012-05-21. Applicant: Novocol, Inc.. Device class: 2.

Clearance details

Applicant: Novocol, Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2012-02-29
Decision date: 2012-05-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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