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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 K222469
Device Name TIB Abutments
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Applicant Contact Leith C. Cumming
Correspondent
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Correspondent Contact Leith C. Cumming
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received08/16/2022
Decision Date 04/17/2023
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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