FDA applicant

Austenal Dental, Inc.

Chicago, IL19 decisions1985–19890 recalls

FDA records 19 decisions for Austenal Dental, Inc. (Chicago, IL) from 1985 to 1989: 19 510(k) clearances. Most are in product codes EJH (Alloy, Metal, Base) and EBI (Resin, Denture, Relining, Repairing, Rebasing). 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 Austenal Dental, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Austenal Dental, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Austenal”

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

Austenal, Inc. 10

Austenal Dental, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Austenal”