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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K232726
Device Name External Hex Implant System
Applicant
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Applicant Contact Colin Saffy
Correspondent
Southern Implants (Pty) Ltd
1 Albert Road
Irene,  ZA 0062
Correspondent Contact Jade Rawlins
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/06/2023
Decision Date 04/01/2024
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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