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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K121583
Device Name CLEARFIL MAJESTY FLOW
Applicant
Kuraray Noritake Dental, Inc.
33 Maiden Lane, 6th Floor
New York,  NY  10038
Applicant Contact KIYOYUKI ARIKAWA
Correspondent
Kuraray Noritake Dental, Inc.
33 Maiden Lane, 6th Floor
New York,  NY  10038
Correspondent Contact KIYOYUKI ARIKAWA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/30/2012
Decision Date 07/25/2012
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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