510(k) Report

FDA applicant

Confi-Dental Products Co.

Louisville, CO31 decisions1989–20030 recalls

FDA records 31 decisions for Confi-Dental Products Co. (Louisville, CO) from 1989 to 2003: 31 510(k) clearances. Most are in product codes EMA (Cement, Dental) and DYH (Adhesive, Bracket And Tooth Conditioner, 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 Confi-Dental Products Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Confi-Dental Products Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Confi-Dental Products Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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