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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K193084
Device Name TIB Abutment System
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Applicant Contact Lauranda G Breytenbach
Correspondent
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Correspondent Contact Lauranda G Breytenbach
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received11/05/2019
Decision Date 10/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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