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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 K132450
Device Name CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Applicant Contact MICHIO TAKIGAWA
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Correspondent Contact MICHIO TAKIGAWA
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received08/06/2013
Decision Date 11/01/2013
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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