510(k) Report

FDA applicant

R-Dental Dentalerzeugnisse GmbH

Hamburg, DE2 decisions2000–20010 recalls

FDA records 2 decisions for R-Dental Dentalerzeugnisse GmbH (Hamburg, DE) from 2000 to 2001: 2 510(k) clearances. All are in product code ELW (Material, Impression). 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 R-Dental Dentalerzeugnisse GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R-Dental Dentalerzeugnisse GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ELWMaterial, Impression2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010926R-SI-Line Metal-BiteR-Dental Dentalerzeugnisse GmbH · 20011cites it

What has FDA decided for it lately?

  • K010926R-SI-Line Metal-BiteR-Dental Dentalerzeugnisse GmbH · 2001
  • K001414KwikkmodelR-Dental Dentalerzeugnisse GmbH · 2000

All 2 as R-Dental Dentalerzeugnisse GmbH →