510(k) Report

FDA applicant

Robodent GmbH

Berlin, DE1 decision2006–20060 recalls

FDA records 1 decision for Robodent GmbH (Berlin, DE) in 2006: 1 510(k) clearance. All are in product code HAW (Neurological Stereotaxic Instrument). Its devices cite 4 predicates, 0 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, neurology panel, where it files most

How often FDA has decided Robodent GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Robodent GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Robodent GmbH’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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Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K061224Lapdoc IRobodent GmbH · 2006

The one decision as Robodent GmbH →