510(k) Report

FDA applicant

Dental X-Ray E.U.

Miami, FL1 decision2005–20050 recalls

FDA records 1 decision for Dental X-Ray E.U. (Miami, FL) in 2005: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). Its devices cite 3 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 Dental X-Ray E.U.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental X-Ray E.U. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental X-Ray E.U. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dental X-Ray E.U.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EHDUnit, X-Ray, Extraoral With Timer1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K043136Elity 70 X-RayDental X-Ray E.U. · 2005

The one decision as Dental X-Ray E.U. →