FDA applicant

Materialise Dental NV

Leuven, BE5 decisions2008–20120 recalls

FDA records 5 decisions for Materialise Dental NV (Leuven, BE) from 2008 to 2012: 5 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 8 predicates, 3 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Materialise Dental NV’s devices, and how often a recall has named them.

FDA decisions per year

3in 2012

2008high 3 (2012) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

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

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Other applicant names beginning “Materialise”

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

Materialise NV 62

Materialise Dental NV

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Materialise”