Device Classification Name |
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device |
510(K) Number |
K151039 |
Device Name |
Abutment, Implant, Dental, Endosseous |
Applicant |
DENTSPLY INTERNATIONAL, INC.
SUSQUEHANNA COMMERCE CTR., 221
W. PHILADELPHIA ST., SUITE 60
YORK, PA 17401 US
Other 510(k) Applications for this Company
|
Contact |
HELEN LEWIS
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 |
04/20/2015 |
Decision Date |
01/14/2016 |
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 |
|