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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 WEST 5TH STREET
THIRD FLOOR
AUSTIN,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
611 WEST 5TH STREET
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
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