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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 Rd.
Guateng,  ZA 0062
Applicant Contact Lauranda G Breytenbach
Correspondent
Southern Implants (Pty), Ltd.
1 Albert Rd.
Guateng,  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
Predetermined Change
Control Plan Authorized		 No
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