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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K253373
Device Name Southern Craniomaxillofacial (CMF) System
Applicant
Southern Medical (Pty) , Ltd.
55 Regency Dr.
Rte. 21 Corporate Park
Irene,  ZA 0062
Applicant Contact Dalene Styger
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received09/30/2025
Decision Date 12/19/2025
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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