FDA applicant

Dentalsafe Systems Pty., Ltd.

Sydney, Australia, AU1 decision1994–19940 recalls

FDA records 1 decision for Dentalsafe Systems Pty., Ltd. (Sydney, Australia, AU) in 1994: 1 510(k) clearance. All are in product code EAX (Mirror, Mouth). 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 Dentalsafe Systems Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentalsafe Systems Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dentalsafe Systems Pty., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Dentalsafe Systems Pty., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?