Manufacturer registered with FDA
Southern Implants, Inc.
IRENE, GAUTENG, South Africa. Lists 4 dental device types with FDA across 1 registered establishment, and holds 22 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 93
- 510(k) clearances
- 222007–2024
- Markets registered in
- 9293 registrations outside the US
- Establishments
- 1South Africa
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Southern Implants, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: South AfricaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Southern Implants, Inc. | 22 clearances | 2007–2024 | Below |
| Canada | Health Canada | Registration holder | SOUTHERN IMPLANTS PTY LTD. | 213 | 2008–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Southern Implants Pty Ltd | 53 | 2012–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Southern Implants(Pty) LtdSOUTHERN IMPLANTS (PTY) LTD. · Southern Implants (Pty) Ltd | 9 | 2008–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Southern Implants (Pty) Ltd | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SOUTHERN IMPLANTS (PTY) LTD | 4 | 2024–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Southern Implants (PTY) Ltd | 4 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Southern Implants (Pty) Ltd.Southern Implants (PTY) Ltd. | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Southern Implants (PTY) Ltd | 1 | 2026–2026 | 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 Implants, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Co-Axis ImplantsDC Implants and AccessoriesDeep Conical Implants and AccessoriesExternal hex anatomical abutmentsExternal Hex Co-Axis Implants 12 degreesExternal Hex Co-Axis Implants 24 degreesExternal hex cobalt chrome abutmentsExternal hex compact conicals abutmentsExternal hex cosmetic abutmentsExternal hex gold abutments abutments 34 moreExternal Hex implant SystemExternal hex implantsExternal hex passive abutmentsExternal hex titanium abutmentsImplant, Endosseous, Root-Form - 12 Deg Co-Axis Tapered ImplantsImplant, Endosseous, Root-Form - Int Oct Parrallel Implant, Internal Oct Tapered ImplantImplant, Endosseous, Root-Form - Internal Oct Parrallel Implants, Internal Oct Tapered ImplantImplant, Endosseous, Root-Form - Max ImplantImplant, Endosseous, Root-Form - NSI hexed and Non hexedImplant, Endosseous, Root-Form - Parrallel ImplantsImplant, Endosseous, Root-Form - Tri-Nex ImplantImplant, Endosseous, Root-Form - Zygomatic ImplantsInversa ImplantsInverta ImplantMAX AbutmentsMAX implantsMSC implantsMSC MAX ImplantsMSC PROMAX AbutmentOncology ImplantsPiccolo AbutmentsPiccolo ImplantsPROMAX AbutmentsPROMAX ImplantsProvata AbutmentsProvata Co-Axis ImplantsPROVATA Implant SystemProvata ImplantsSingle Platform SP1 Implant System and accessoriesTRIMAX AbutmentsTRIMAX ImplantsZAGA AbutmentsZAGA Zygomatic SystemZygan Implants | 2010 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Angulated Screw Channel Solution Abutments & SI-BASE AbutmentsDC Implants and AccessoriesDeep Conical Implants and AccessoriesExternal hex anatomical abutmentsExternal Hex Co-Axis Implants 12 degreesExternal Hex Co-Axis Implants 24 degreesExternal hex cobalt chrome abutmentsExternal hex compact conicals abutmentsExternal hex cosmetic abutmentsExternal hex gold abutments abutments 30 moreExternal hex implantsExternal hex passive abutmentsExternal hex titanium abutmentsImplant, Endosseous, Root-Form - Int Oct Parrallel Implant, Internal Oct Tapered ImplantImplant, Endosseous, Root-Form - Max ImplantImplant, Endosseous, Root-Form - Tri-Nex ImplantMAX AbutmentsMAX implantsMSC implantsMSC MAX ImplantsMSC PROMAX AbutmentOncology ImplantsPEEK AbutmentsPiccolo AbutmentsPiccolo ImplantsPiccolo PEEK AbutmentsPROMAX AbutmentsPROMAX ImplantsProvata AbutmentsProvata Co-Axis ImplantsPROVATA Implant SystemProvata ImplantsProvata PEEK AbutmentsSingle Platform SP1 Implant System and accessoriesTIB Abutment SystemTIB AbutmentsTRIMAX AbutmentsTRIMAX ImplantsZAGA AbutmentsZygan Implants | 2010 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | Angulated Screw Channel Solution Abutments & SI-BASE AbutmentsPROVATA Implant SystemSingle Platform SP1 Implant System and accessoriesTIB Abutment SystemTIB Abutments | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Drill, Tools and Accessories, Dental, Intraorallaboratory pieces used for fabrication of dental prostheticsPlacement and removal tools, Dental, Intraoralscrewdrivers, Dental, Intraoral | 2005 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Southern Implants, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Apr 2024 | K232726 | External Hex Implant System | DZE Root-Form Endosseous Implant |
| 1 Dec 2023 | K232418 | Single Platform SP1 Implant System | DZE Root-Form Endosseous Implant |
| 1 Aug 2023 | K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | NHA Endosseous Dental Implant Abutment |
| 17 Apr 2023 | K222469 | TIB Abutments | NHA Endosseous Dental Implant Abutment |
| 6 Mar 2023 | K222457 | Provata Implant System | DZE Root-Form Endosseous Implant |
| 9 Nov 2022 | K222497 | Zaga Zygomatic System | DZE Root-Form Endosseous Implant |
| 27 Oct 2020 | K193084 | TIB Abutment System | NHA Endosseous Dental Implant Abutment |
| 7 May 2020 | K192651 | ZAGA Zygomatic System | DZE Root-Form Endosseous Implant |
| 9 Dec 2019 | K191054 | Southern Implants MAX Implant System | DZE Root-Form Endosseous Implant |
| 5 Dec 2019 | K191250 | Southern Implants PEEK Abutments | NHA Endosseous Dental Implant Abutment |
| 14 Nov 2018 | K181850 | Inversa Implants | DZE Root-Form Endosseous Implant |
| 6 Sep 2018 | K180465 | Provata Implant System | DZE Root-Form Endosseous Implant |
| 8 Jun 2018 | K173706 | Piccolo Implants and Accessories | DZE Root-Form Endosseous Implant |
| 27 Feb 2018 | K173343 | Zygomatic Implant System | DZE Root-Form Endosseous Implant |
| 9 Feb 2018 | K172160 | Southern Implants PEEK Abutments | NHA Endosseous Dental Implant Abutment |
| 6 Nov 2017 | K163634 | External Hex Implants | DZE Root-Form Endosseous Implant |
| 13 Jun 2017 | K163060 | Deep Conical (DC) Implants and Accessories | DZE Root-Form Endosseous Implant |
| 14 Oct 2010 | K093562 | ENDOSSEOUS DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 22 Dec 2008 | K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Nov 2007 | K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Jun 2007 | K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 24 May 2007 | K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Keystone Dental Inc. (5).
Also lists devices cleared under other names
Southern Implants, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Northern Implants, LLC (3), Nsi (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Jun 2006 | K061169 | ENDOSSEOUS DENTAL IMPLANT | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 5 Apr 2006 | K053478 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 8 Dec 2005 | K052490 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | Northern Implants, LLC | DZE Root-Form Endosseous Implant |
| 10 May 2002 | K020617 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | DZE Root-Form Endosseous Implant |
| 19 Sep 2001 | K003620 | NSI HEXED AND NON-HEXED IMPLANT SYSTEM | Nsi | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOUTHERN IMPLANTS (PTY) LTDFDA reg. 3003394627 | IRENE Gauteng, South Africa | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9073913). 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.