FDA applicant

Dirotian Pty., Ltd.

South Australia, AU1 decision1990–19900 recalls

FDA records 1 decision for Dirotian Pty., Ltd. (South Australia, AU) in 1990: 1 510(k) clearance. All are in product code EKO (Denture Preformed (Partially Prefabricated…). 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 Dirotian Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dirotian Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dirotian Pty., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Dirotian Pty., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?