Aurex SA (Pty) , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aurex SA (Pty) , Ltd.” (first 2000, latest 2000), across 1 product code in 1 review panel. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 6 | 6 |
Review panels
- Dental (6)
Most recent Aurex SA (Pty) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001482 | AURENORM 75 KF | EJT | 2000-06-23 | 43 |
| K001481 | PALCERAM 49 | EJT | 2000-06-23 | 43 |
| K001480 | AURECAST 40 B | EJT | 2000-06-21 | 41 |
| K001479 | PALCERAM 53 | EJT | 2000-06-21 | 41 |
| K001478 | AURECAST SUPER INLAY | EJT | 2000-06-20 | 40 |
| K001477 | AURELUX Y 84 PREMIUM | EJT | 2000-06-20 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Aurex SA (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.
- Aurex Precious Metal Industries (Pty)Ltd (19 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aurex SA (Pty) , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Aurex SA (Pty) , Ltd.” (first 2000, latest 2000), 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 Aurex SA (Pty) , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aurex SA (Pty) , Ltd. is 41 days.
Which FDA product codes appear under Aurex SA (Pty) , Ltd.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 6).
Next steps
- See all 6 Aurex SA (Pty) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Aurex SA (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 (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.