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FDA 510(k) Application Details - K163398
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K163398
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60
York, PA 17404 US
Other 510(k) Applications for this Company
Contact
Karl Nittinger
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
12/05/2016
Decision Date
08/14/2017
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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