510(k) Report

FDA applicant

Miras Mirror Imaging Solutions, Ltd.

Ramat-Gan, IL1 decision2004–20040 recalls

FDA records 1 decision for Miras Mirror Imaging Solutions, Ltd. (Ramat-Gan, IL) in 2004: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). 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 Miras Mirror Imaging Solutions, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Miras Mirror Imaging Solutions, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Miras Mirror Imaging Solutions, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Miras Mirror Imaging Solutions, Ltd.’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?

  • EIAUnit, Operative Dental1decision

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?

  • K041805Microscope SystemMiras Mirror Imaging Solutions, Ltd. · 2004

The one decision as Miras Mirror Imaging Solutions, Ltd. →