FDA applicant

Challenge Products, Inc.

Chicago, IL4 decisions1985–19970 recalls

FDA records 4 decisions for Challenge Products, Inc. (Chicago, IL) from 1985 to 1997: 4 510(k) clearances. Most are in product codes EJR (Agent, Polishing, Abrasive, Oral Cavity) and EJK (Liner, Cavity, Calcium Hydroxide). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Challenge Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Challenge Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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See the 510(k) Report

Other applicant names beginning “Challenge”

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

Challenge Mfg., Inc. 4

Challenge Products, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Challenge”