FDA · official record K062410Substantially Equivalent

CLEARFIL ESTHETIC CEMENT & DC BOND

Name: CLEARFIL ESTHETIC CEMENT & DC BOND — FDA K062410
Creator: Kuraray Medical, Inc.
Keywords: CLEARFIL ESTHETIC CEMENT & DC BOND, CLEARFIL ESTHETIC CEMENT & DC BOND, K062410, EMA, FDA

United StatesEMAKuraray Medical, Inc.

Verified

Official record identity

FDA application number: K062410
Decision date: September 26, 2006
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Kuraray Medical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-08-17
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3275

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.