FDA applicant

Dentauraum, Inc.

Newtown, PA24 decisions1991–19950 recalls

FDA records 24 decisions for Dentauraum, Inc. (Newtown, PA) from 1991 to 1995: 24 510(k) clearances. Most are in product codes EJH (Alloy, Metal, Base) and EJF (Bracket, Metal, Orthodontic). 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 Dentauraum, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentauraum, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Dentauraum, 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?