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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 K230873
Device Name Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Applicant
Southern Implants (Pty), Ltd.
1 Albert Rd.
Guateng,  ZA 0062
Applicant Contact Colin Saffy
Correspondent
Southern Implants (Pty), Ltd.
1 Albert Rd.
Guateng,  ZA 0062
Correspondent Contact Colin Saffy
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received03/30/2023
Decision Date 08/01/2023
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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