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FDA 510(k) Application Details - K172854
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K172854
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Nobel Biocare AB
BOX 5190, SE-402 26, Vastra Hamngatan 1
Goteborg SE-411 17 SE
Other 510(k) Applications for this Company
Contact
Charlemagne Chua
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
09/20/2017
Decision Date
12/14/2017
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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