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FDA 510(k) Application Details - K150012
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K150012
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
CREODENT PROSTHETICS, LTD.
29 WEST 30TH STREET, 11TH FLOOR
NEW YORK, NY 10001 US
Other 510(k) Applications for this Company
Contact
CALVIN SHIM
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2015
Decision Date
06/04/2015
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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