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FDA 510(k) Application Details - K122295
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K122295
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
CORE 3D PROTECH, S.L.
POL. IND. SANTA ANNA
APARTAT 20
SANTPEDOR 08251 ES
Other 510(k) Applications for this Company
Contact
ANNA CORTINA
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
07/31/2012
Decision Date
10/24/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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