FDA applicant
Southern Implants (Pty), Ltd.
FDA records 24 decisions for Southern Implants (Pty), Ltd. (Guateng, ZA) from 2007 to 2024: 24 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 207 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 84 predicates, 24 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Southern Implants, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Southern Implants (Pty), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Southern Implants (Pty), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report