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FDA 510(k) Application Details - K193084
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K193084
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
Irene 0062 ZA
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Contact
Lauranda G Breytenbach
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
11/05/2019
Decision Date
10/27/2020
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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