FDA applicant

Vertex-Dental B.V.

Soesterberg, NL8 decisions2010–20240 recalls

FDA records 8 decisions for Vertex-Dental B.V. (Soesterberg, NL) from 2010 to 2024: 8 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 12 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, dental panel, where it files most

How often FDA has decided Vertex-Dental B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Vertex-Dental B.V. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vertex-Dental B.V.’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 “Vertex-Dental”

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

Vertex Medical Corp. 21 Vertex Technical Group, Inc. 1

Vertex-Dental B.V.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Vertex-Dental”