FDA applicant

Pemaco, Inc.

Fenton, MO7 decisions1989–19910 recalls

FDA records 7 decisions for Pemaco, Inc. (Fenton, MO) from 1989 to 1991: 7 510(k) clearances. All are in product code EGD (Wax, Dental, Intraoral). 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 Pemaco, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pemaco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pemaco, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Pemaco, Inc.

Which product codes does it file in?

What has FDA decided for it lately?