CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND— 510(k) K131432

Name: FDA 510(k) clearance K131432
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Substantially Equivalent

Kuraray Noritake Dental, Inc.

FDA 510(k) clearance K131432 for CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND, Substantially Equivalent on 2013-08-22. Applicant: Kuraray Noritake Dental, Inc.. Device class: 2.

Clearance details

Device name as filed: CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
Applicant: Kuraray Noritake Dental, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2013-05-17
Decision date: 2013-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiyoda-Ku, JP

Download summary PDF View on FDA.gov ↗

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