FDA applicant

Aproxi Aps

Vaerlose, DK1 decision2008–20080 recalls

FDA records 1 decision for Aproxi Aps (Vaerlose, DK) in 2008: 1 510(k) clearance. All are in product code EBF (Material, Tooth Shade, Resin). 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 Aproxi Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Aproxi Aps by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Aproxi Aps

Which product codes does it file in?

What has FDA decided for it lately?