Southern Implants
Also known as: Southern Implants (Pty) Ltd
A privately owned South African implant manufacturer known for site-specific designs, including zygomatic and pterygoid implants.
Key facts
| Headquarters | 1 Albert Road, Irene, South AfricaVerified spec[1] |
|---|---|
| Country | South AfricaVerified spec[1] |
| Founded | 1987, by the engineer Graham BlackbeardVerified spec[1] |
| Ownership | Privately ownedManufacturer-reported[1] |
| Brand | Southern ImplantsManufacturer-reported[1] |
| Manufacturer-described indication | Positions itself towards clinicians treating complex and site-specific cases, including zygomatic, pterygoid, anterior and molar indicationsManufacturer-reported[1] |
| manufacturingCountry | South AfricaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance17 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | 2024-04-01 |
| K232418 | Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. | 2023-12-01 |
| K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023-03-06 |
| K222497 | Zaga Zygomatic System | Southern Implants (Pty), Ltd. | 2022-11-09 |
| K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020-05-07 |
| K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | 2019-12-09 |
| K181850 | Inversa Implants | Southern Implants (Pty), Ltd. | 2018-11-14 |
| K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018-09-06 |
| K173706 | Piccolo Implants and Accessories | Southern Implants (Pty), Ltd. | 2018-06-08 |
| K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018-02-27 |
| K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017-11-06 |
| K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017-06-13 |
| K093562 | ENDOSSEOUS DENTAL IMPLANT | Southern Implants, Inc. | 2010-10-14 |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2008-12-22 |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-11-16 |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-06-21 |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Southern Implants, Inc. | 2007-05-24 |
Other2 records
Registered device establishment in South Africa. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3003394627 | — | SOUTHERN IMPLANTS (PTY) LTD | — |
| 954 device records | — | Southern Implants | — |
Clearance records for Southern Implants were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Southern Implants.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Profile — Southern Implants — Southern Implants (Pty) Ltd. Accessed 2026-07-21.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.