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FDA 510(k) Application Details - K181381
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K181381
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
A.B Dental Device Ltd.
19 Hayalomim St.
Ashdod 7761117 IL
Other 510(k) Applications for this Company
Contact
Gabi Krauss
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
05/24/2018
Decision Date
11/23/2018
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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