510(k) Report

FDA applicant

Oraltronics Marketing-Und Vertriebs GmbH

San Diego, CA1 decision1999–19990 recalls

FDA records 1 decision for Oraltronics Marketing-Und Vertriebs GmbH (San Diego, CA) in 1999: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 6 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, dental panel, where it files most

How often FDA has decided Oraltronics Marketing-Und Vertriebs GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oraltronics Marketing-Und Vertriebs GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oraltronics Marketing-Und Vertriebs 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?

  • DZEImplant, Endosseous, Root-Form1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K983120Bicortical ScrewOraltronics Marketing-Und Vertriebs GmbH · 19993cite it

What has FDA decided for it lately?

  • K983120Bicortical ScrewOraltronics Marketing-Und Vertriebs GmbH · 1999

The one decision as Oraltronics Marketing-Und Vertriebs GmbH →

Other applicant names beginning “Oraltronics”

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

Oraltronics Dental Implant Technology GmbH 1