510(k) Report

FDA applicant

American Dental Research

Mchenry, IL5 decisions1980–19800 recalls

FDA records 5 decisions for American Dental Research (Mchenry, IL) in 1980: 5 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EBC (Sealant, Pit And Fissure, And Conditioner). 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 American Dental Research’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Dental Research since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Dental Research’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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