Southern Implants, (Pty.) Ltd.
IRENE Gauteng, ZA
SOUTHERN IMPLANTS (PTY) LTD appears in FDA device records in IRENE Gauteng, ZA. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Southern Implants, (Pty.) Ltd. between 2007 and 2024. The busiest year on record is 2018, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| 2008 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 2 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232726 | External Hex Implant System | DZE | Substantially Equivalent | |
| K232418 | Single Platform SP1 Implant System | DZE | Substantially Equivalent | |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | NHA | Substantially Equivalent | |
| K222469 | TIB Abutments | NHA | Substantially Equivalent | |
| K222457 | Provata Implant System | DZE | Substantially Equivalent | |
| K222497 | Zaga Zygomatic System | DZE | Substantially Equivalent | |
| K210923 | Southern Implants Instrument Trays | KCT | Substantially Equivalent | |
| K193084 | TIB Abutment System | NHA | Substantially Equivalent | |
| K192651 | ZAGA Zygomatic System | DZE | Substantially Equivalent | |
| K191054 | Southern Implants MAX Implant System | DZE | Substantially Equivalent | |
| K191250 | Southern Implants PEEK Abutments | NHA | Substantially Equivalent | |
| K181850 | Inversa Implants | DZE | Substantially Equivalent | |
| K180465 | Provata Implant System | DZE | Substantially Equivalent | |
| K173706 | Piccolo Implants and Accessories | DZE | Substantially Equivalent | |
| K173343 | Zygomatic Implant System | DZE | Substantially Equivalent | |
| K172160 | Southern Implants PEEK Abutments | NHA | Substantially Equivalent | |
| K163634 | External Hex Implants | DZE | Substantially Equivalent | |
| K163060 | Deep Conical (DC) Implants and Accessories | DZE | Substantially Equivalent | |
| K161548 | Osseointegrated Fixtures | FZE | Substantially Equivalent | |
| K093562 | ENDOSSEOUS DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003394627 | 3003394627 | SOUTHERN IMPLANTS (PTY) LTD | ONE ALBERT ROAD, IRENE Gauteng 0062 ZA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- PNPDental Abutment Design Software For Dental Laboratory
- DZEImplant, Endosseous, Root-Form
- NOKMaterial, External Aesthetic Restoration, No Adhesive
- FZEProsthesis, Nose, Internal
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1386-2018 | SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. | The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. | Class II | Terminated | |
| Z-1265-2015 | MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. | Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa. | Class II | Terminated | |
| Z-0382-2014 | Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. | Southern Implants is recalling the Tri-Nex healing abutment because the package was incorrectly labeled and packaged as the Tri-Nex healing abutment, 05.0 mm x 5 mm height (HA-L-50-5). The package contains the Tri-Nex healing abutment 05.0 mm x 6.0 mm Flare x 5 mm Height (HA-L-50W-5). | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain