Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South AfricaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Southern Implants with 24 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Apr 1, 2024: External Hex Implant System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 1, 2024 | External Hex Implant SystemK232726 · DZE | 510(k) clearances |
| Dec 1, 2023 | Single Platform SP1 Implant SystemK232418 · DZE | 510(k) clearances |
| Aug 1, 2023 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsK230873 · NHA | 510(k) clearances |
| Apr 17, 2023 | TIB AbutmentsK222469 · NHA | 510(k) clearances |
| Mar 6, 2023 | Provata Implant SystemK222457 · DZE | 510(k) clearances |
| Nov 9, 2022 | Zaga Zygomatic SystemK222497 · DZE | 510(k) clearances |
| Mar 2, 2022 | Southern Implants Instrument TraysK210923 · KCT | 510(k) clearances |
| Oct 27, 2020 | TIB Abutment SystemK193084 · NHA | 510(k) clearances |
| Mar 8, 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 proClass II · The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
