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FDA 510(k) Application Details - K111291
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K111291
Device Name
Powder, Porcelain
Applicant
QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD
611 WEST 5TH STREET
THIRD FLOOR
AUSTIN, TX 78701 US
Other 510(k) Applications for this Company
Contact
STUART R GOLDMAN
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2011
Decision Date
07/20/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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