510(k) Report

FDA applicant

Midwest Orthodontic Mfg.

Columbus, IN7 decisions1990–19980 recalls

FDA records 7 decisions for Midwest Orthodontic Mfg. (Columbus, IN) from 1990 to 1998: 7 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and EJF (Bracket, Metal, Orthodontic). 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 Midwest Orthodontic Mfg.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Midwest Orthodontic Mfg. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Midwest Orthodontic Mfg.’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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Other applicant names beginning “Midwest”

FDA records each applicant name separately; these may or may not be the same firm.