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FDA 510(k) Application Details - K162323
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K162323
Device Name
Material, Tooth Shade, Resin
Applicant
LIAONING UPCERA CO.,LTD
NO.122 XIANGHUAI ROAD, ECONOMIC DEVELOPMENT ZONE
BENXI 117004 CN
Other 510(k) Applications for this Company
Contact
Charles Shen
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/2016
Decision Date
01/12/2017
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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