Southern Implants (Pty), Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Southern Implants (Pty), Ltd.” (first 2016, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 206 days. Since 2017 the median was 207 days, against 188 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 181 |
| 2017 | 2 | 272 |
| 2018 | 5 | 186 |
| 2019 | 2 | 222 |
| 2020 | 2 | 292 |
| 2021 | 0 | — |
| 2022 | 2 | 210 |
| 2023 | 4 | 164 |
| 2024 | 1 | 208 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Southern Implants (Pty), Ltd. took a median 207 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 | 12 |
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Dental (17)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Southern Implants (Pty), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232726 | External Hex Implant System | DZE | 2024-04-01 | 208 |
| K232418 | Single Platform SP1 Implant System | DZE | 2023-12-01 | 112 |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | NHA | 2023-08-01 | 124 |
| K222469 | TIB Abutments | NHA | 2023-04-17 | 244 |
| K222457 | Provata Implant System | DZE | 2023-03-06 | 203 |
| K222497 | Zaga Zygomatic System | DZE | 2022-11-09 | 83 |
| K210923 | Southern Implants Instrument Trays | KCT | 2022-03-02 | 338 |
| K193084 | TIB Abutment System | NHA | 2020-10-27 | 357 |
| K192651 | ZAGA Zygomatic System | DZE | 2020-05-07 | 226 |
| K191054 | Southern Implants MAX Implant System | DZE | 2019-12-09 | 234 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Southern Implants (Pty), Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Southern Dental Industries, Inc. (24 510(k)s)
- Southern Medical (Pty) , Ltd. (6 510(k)s)
- Southern Implants, Inc. (5 510(k)s)
- Southern Spine, LLC (4 510(k)s)
- Southern Medical Products, Inc. (2 510(k)s)
- Southern Exposure, Inc. (1 510(k)s)
- Southern Pride Manufacturing, Inc. (1 510(k)s)
- Southern Research, Inc. (1 510(k)s)
- Southern Rubber Industries Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Southern Implants (Pty), Ltd.?
FDA lists 19 510(k) clearances under the applicant name “Southern Implants (Pty), Ltd.” (first 2016, latest 2024), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Southern Implants (Pty), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Southern Implants (Pty), Ltd. is 206 days. Since 2017: 207 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Southern Implants (Pty), Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 12); NHA (Abutment, Implant, Dental, Endosseous, 5); FZE (Prosthesis, Nose, Internal, 1).
Next steps
- See all 19 Southern Implants (Pty), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Southern Implants (Pty), Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.