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FDA 510(k) Application Details - K170421
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K170421
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Hiossen Inc.
85 Ben Fairless Dr.
Fairless Hills, PA 19030 US
Other 510(k) Applications for this Company
Contact
David Kim
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
02/13/2017
Decision Date
01/11/2018
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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