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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 K120852
Device Name ZIRCONIA BLANKS (ZIRCOSTAR)
Applicant
KEROX LTD
55 northern blvd
suite 200
great neck,  NY  11021
Contact sangram yadav
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/21/2012
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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