510(k) Report

FDA applicant

Aurex Precious Metal Industries (Pty)Ltd

Edenvale, ZA19 decisions1997–19970 recalls

FDA records 19 decisions for Aurex Precious Metal Industries (Pty)Ltd (Edenvale, ZA) in 1997: 19 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EJS (Alloy, Other Noble Metal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Aurex Precious Metal Industries (Pty)Ltd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aurex Precious Metal Industries (Pty)Ltd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aurex Precious Metal Industries (Pty)Ltd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Aurex”

FDA records each applicant name separately; these may or may not be the same firm.