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FDA 510(k) Application Details - K113263
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K113263
Device Name
Material, Impression
Applicant
ARGES IMAGING, INC
129 NORTH HILL AVENUE
PASADENA, CA 91106 US
Other 510(k) Applications for this Company
Contact
Rebecca K Pine
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/04/2011
Decision Date
11/14/2011
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
Y
Expedited Review
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