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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 K161042
Device Name CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
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  
Date Received04/13/2016
Decision Date 10/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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