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FDA 510(k) Application Details - K130216
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K130216
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
DENTSPLY IMPLANT
12264 EL CAMINO REAL
SUITE 400
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
LINDA K SCHULZ
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
01/29/2013
Decision Date
05/01/2013
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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