CLEARFIL MAJESTY POSTERIOR— 510(k) K063595

Name: FDA 510(k) clearance K063595
Creator: U.S. Food and Drug Administration
Published: 2007-02-09

Substantially Equivalent

Kuraray America, Inc.

FDA 510(k) clearance K063595 for CLEARFIL MAJESTY POSTERIOR, Substantially Equivalent on 2007-02-09. Applicant: Kuraray America, Inc.. Device class: 2.

Clearance details

Applicant: Kuraray America, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2006-12-04
Decision date: 2007-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.