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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
Applicant Contact SANGRAM YADAV
Correspondent
KEROX LTD
55 Northern Blvd
Suite 200
Great Neck,  NY  11021
Correspondent Contact SANGRAM YADAV
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/21/2012
Decision Date 06/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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