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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K170834
Device Name CERABIEN ZR
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
Chiyoda-Ku,  JP 100-0004
Applicant Contact Yasujiro Ohara
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
Chiyoda-Ku,  JP 100-0004
Correspondent Contact Yasujiro Ohara
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/20/2017
Decision Date 10/17/2017
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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