Southern Implants, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Southern Implants, Inc.” (first 2007, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 101 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
Review panels
- Dental (5)
Most recent Southern Implants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093562 | ENDOSSEOUS DENTAL IMPLANT | DZE | 2010-10-14 | 330 |
| K082651 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | 2008-12-22 | 101 |
| K071161 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | 2007-11-16 | 204 |
| K070841 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | 2007-06-21 | 86 |
| K070905 | ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | 2007-05-24 | 52 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-01-23.
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. (21 510(k)s)
- Southern Implants (Pty), Ltd. (19 510(k)s)
- Southern Medical (Pty) , Ltd. (6 510(k)s)
- Southern Spine, LLC (4 510(k)s)
- Southern Dental Industries, Ltd. (3 510(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, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Southern Implants, Inc.” (first 2007, latest 2010), across 1 product code in 1 review panel. 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Southern Implants, Inc. is 101 days.
Which FDA product codes appear under Southern Implants, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5).
Next steps
- See all 5 Southern Implants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Southern Implants, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.