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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 K121980
Device Name ZIRPRIME
Applicant
KURARAY NORITAKE DENTAL INC.
700 12TH ST SW
SUITE 100
WASHINGTON,  DC  20005
Applicant Contact IVAN WASSERMAN
Correspondent
KURARAY NORITAKE DENTAL INC.
700 12TH ST SW
SUITE 100
WASHINGTON,  DC  20005
Correspondent Contact IVAN WASSERMAN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/06/2012
Decision Date 10/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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