510(k) Report

FDA applicant

Pennwalt Corp.

Mchenry, IL6 decisions1978–19830 recalls

FDA records 6 decisions for Pennwalt Corp. (Mchenry, IL) from 1978 to 1983: 6 510(k) clearances. Most are in product codes EAP (Unit, X-Ray, Intraoral) and EJK (Liner, Cavity, Calcium Hydroxide). 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 Pennwalt Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pennwalt Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pennwalt 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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