FDA applicant

Eurodent, Inc.

Canada J4b 5z5, CA6 decisions1979–20050 recalls

FDA records 6 decisions for Eurodent, Inc. (Canada J4b 5z5, CA) from 1979 to 2005: 6 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and KLC (Chair, Dental, With Operative Unit). No recall is linked to its devices.

FDA’s records also spell it “Eurodent S.P.A.”.

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 Eurodent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eurodent, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eurodent, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eurodent, Inc.’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

Eurodent, Inc.

Which product codes does it file in?

What has FDA decided for it lately?