Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southern Implants (Pty), Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
338 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | 2024-04-01 | 208 | 0 |
| K232418 | Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. | 2023-12-01 | 112 | 0 |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE A | Southern Implants (Pty), Ltd. | 2023-08-01 | 124 | 0 |
| K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | 2023-04-17 | 244 | 0 |
| K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | 2023-03-06 | 203 | 0 |
| K222497 | Zaga Zygomatic System | Southern Implants (Pty), Ltd. | 2022-11-09 | 83 | 0 |
| K210923 | Southern Implants Instrument Trays | Southern Implants (Pty), Ltd. | 2022-03-02 | 338 | 0 |
| K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020-10-27 | 357 | 0 |
| K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | 2020-05-07 | 226 | 0 |
| K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | 2019-12-09 | 234 | 0 |
| K191250 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | 2019-12-05 | 210 | 0 |
| K181850 | Inversa Implants | Southern Implants (Pty), Ltd. | 2018-11-14 | 126 | 0 |
| K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018-09-06 | 197 | 0 |
| K173706 | Piccolo Implants and Accessories | Southern Implants (Pty), Ltd. | 2018-06-08 | 186 | 0 |
| K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018-02-27 | 126 | 0 |
| K172160 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | 2018-02-09 | 206 | 0 |
| K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017-11-06 | 319 | 0 |
| K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | 2017-06-13 | 224 | 0 |
| K161548 | Osseointegrated Fixtures | Southern Implants (Pty), Ltd. | 2016-12-01 | 181 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda