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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K111975
Device Name CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK
Applicant
Kuraray Medical, Inc.
Ote Center Bld
7f, 1-1-3, Otemachi
Chiyoda-Ku, Tokyo,  JP 100-0004
Applicant Contact MICHIO TAKIGAWA
Correspondent
Kuraray Medical, Inc.
Ote Center Bld
7f, 1-1-3, Otemachi
Chiyoda-Ku, Tokyo,  JP 100-0004
Correspondent Contact MICHIO TAKIGAWA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/12/2011
Decision Date 10/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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