510(k) Report

FDA applicant

Medental Intl.

Evergreen, CO7 decisions1997–19990 recalls

FDA records 7 decisions for Medental Intl. (Evergreen, CO) from 1997 to 1999: 7 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). 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 Medental Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medental Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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