CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack— 510(k) K161042

Name: FDA 510(k) clearance K161042
Creator: U.S. Food and Drug Administration
Published: 2016-10-25

Substantially Equivalent

Kuraray Noritake Dental, Inc.

FDA 510(k) clearance K161042 for CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack, Substantially Equivalent on 2016-10-25. Applicant: Kuraray Noritake Dental, Inc.. Device class: 2.

Clearance details

Applicant: Kuraray Noritake Dental, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2016-04-13
Decision date: 2016-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

Download summary PDF View on FDA.gov ↗

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