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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 K153476
Device Name KATANA AVENCIA Block
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 Number872.3690
Classification Product Code
EBF  
Date Received12/02/2015
Decision Date 08/23/2016
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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