Dental device manufacturers in South Africa
4 companies have an FDA-registered establishment in South Africa, across 4 sites. 3 manufacture dental devices there or own their specifications.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Southern Implants, Inc. | South Africa | Maker | Co-Axis Implants · DC Implants and Accessories · Deep Conical Implants and Accessories · External hex anatomical abutments · +50 | 22 | 2024 |
| Southern Medical (Pty) Ltd | South Africa | Maker | Southern Maxillofacial (MF) system | 1 | 2025 |
| AD Systems And Consulting (Pty) Ltd. | South Africa | Maker | Denture Base Resi n DT20 | — | — |
| STERIS Corporation | United States | Maker | Accumedix377 (LS) - Blue Sky Bio Dental Implant System - Internal Octagon Taper; Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / Conus · +99 | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026