510(k) Report

FDA applicant

Mion International Corp.

Winslow, IN3 decisions1992–19940 recalls

FDA records 3 decisions for Mion International Corp. (Winslow, IN) from 1992 to 1994: 3 510(k) clearances. All are in product code EMA (Cement, Dental). 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 Mion International Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mion International Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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