FDA applicant

The Hygenic Corp.

Akron, OH16 decisions1979–19960 recalls

FDA records 16 decisions for The Hygenic Corp. (Akron, OH) from 1979 to 1996: 16 510(k) clearances. Most are in product codes EGD (Wax, Dental, Intraoral) and EAT (Tester, Pulp). 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 The Hygenic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Hygenic Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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The Hygenic Corp.

Which product codes does it file in?

What has FDA decided for it lately?