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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 K133211
Device Name ZIRTOUGH
Applicant
Kuraray Noritake Dental, Inc.
700 12th St., NW
Suite 1100
Washington,  DC  20005
Applicant Contact MICHIO TAKIGAWA
Correspondent
Kuraray Noritake Dental, Inc.
700 12th St., NW
Suite 1100
Washington,  DC  20005
Correspondent Contact MICHIO TAKIGAWA
Regulation Number872.6660
Classification Product Code
EIH  
Date Received10/18/2013
Decision Date 03/20/2014
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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