Aurex Precious Metal Industries (Pty)Ltd: FDA clearances and approvals
Aurex Precious Metal Industries (Pty)Ltd has 19 FDA 510(k) clearances (first 1997, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time: 77 days.
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 | 18 | 18 |
| EJS | Alloy, Other Noble Metal | 1 | 1 |
Review panels
- Dental (19)
Most recent Aurex Precious Metal Industries (Pty)Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972946 | AURELUX 77 | EJT | 1997-12-19 | 182 |
| K972945 | AURENORM 68 | EJS | 1997-11-26 | 159 |
| K972949 | AURELUX BIO Y85PF | EJT | 1997-09-18 | 90 |
| K972943 | AURECAST 92 | EJT | 1997-09-16 | 88 |
| K972956 | PALCERAM 82SF | EJT | 1997-09-05 | 77 |
| K972955 | PALCERAM 56 | EJT | 1997-09-05 | 77 |
| K972954 | PALAUREX 78 | EJT | 1997-09-05 | 77 |
| K972953 | PALAUREX 76KF | EJT | 1997-09-05 | 77 |
| K972952 | AUREBOND 51 | EJT | 1997-09-05 | 77 |
| K972951 | HIPALLAUR 51 | EJT | 1997-09-05 | 77 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aurex Precious Metal Industries (Pty)Ltd.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Aurex Precious Metal Industries (Pty)Ltd have?
Aurex Precious Metal Industries (Pty)Ltd has 19 FDA 510(k) clearances (first 1997, latest 1997), across 2 product codes in 1 review panel.
How long does FDA take to clear Aurex Precious Metal Industries (Pty)Ltd's 510(k)s?
The median time from FDA receipt to decision across Aurex Precious Metal Industries (Pty)Ltd's cleared 510(k)s is 77 days.
What devices does Aurex Precious Metal Industries (Pty)Ltd make?
Its most frequent FDA product codes are EJT (Alloy, Gold-Based Noble Metal, 18); EJS (Alloy, Other Noble Metal, 1).
Has Aurex Precious Metal Industries (Pty)Ltd had device recalls?
openFDA lists no recalls under a recalling firm name matching Aurex Precious Metal Industries (Pty)Ltd. Related entities may recall under other names.
Next steps
- See all 19 Aurex Precious Metal Industries (Pty)Ltd clearances with predicates and recalls
- Run predicate analysis for product code EJT, Aurex Precious Metal Industries (Pty)Ltd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.