Manufacturer registered with FDA
Southern Medical (Pty) Ltd
Pretoria, South Africa. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12025–2025
- Markets registered in
- 27 registrations outside the US
- Establishments
- 1South Africa
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Southern Medical (Pty) Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Southern Medical (Pty) Ltd | 1 clearances | 2025–2025 | Below |
| Australia | TGA | Manufacturer | Southern Medical (PTY) Ltd | 7 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Southern Medical (Pty) Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Southern Maxillofacial (MF) system | 2026 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Southern Maxillofacial (MF) system | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOUTHERN MEDICAL (PTY) LTDFDA reg. 3003898943 | IRENE Gauteng, South Africa | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052759). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.