510(k) Report

FDA applicant

Visiodent SA

Ormond Beach, FL1 decision2003–20030 recalls

FDA records 1 decision for Visiodent SA (Ormond Beach, FL) in 2003: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). 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 Visiodent SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Visiodent SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Visiodent SA 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?

  • EHDUnit, X-Ray, Extraoral With Timer1decision

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.

  • K031448RSV (Radiology System VisiodentVisiodent SA · 20033cite it

What has FDA decided for it lately?

  • K031448RSV (Radiology System VisiodentVisiodent SA · 2003

The one decision as Visiodent SA →