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FDA 510(k) Application Details - K202144
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K202144
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
A.B. Dental Device Ltd.
19 Hayalomim Street
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
07/31/2020
Decision Date
09/23/2022
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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