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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 K140491
Device Name TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
Applicant
Tanaka Dental
8944 Tamaroa Ter.
Skokie,  IL  60076
Applicant Contact BETSY A BROWN
Correspondent
Tanaka Dental
8944 Tamaroa Ter.
Skokie,  IL  60076
Correspondent Contact BETSY A BROWN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received02/27/2014
Decision Date 05/20/2015
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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