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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 K111291
Device Name AIDITE ZIRCONIA DENTAL CERAMICS
Applicant
Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.
611 W. 5th St. Third Floor
Austin,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.
611 W. 5th St. Third Floor
Austin,  TX  78701
Correspondent Contact STUART R GOLDMAN
Regulation Number872.6660
Classification Product Code
EIH  
Subsequent Product Code
ELL  
Date Received05/06/2011
Decision Date 07/20/2011
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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