FDA applicant

Dentaurum

Newtown, PA10 decisions2001–20060 recalls

FDA records 10 decisions for Dentaurum (Newtown, PA) from 2001 to 2006: 10 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and OAT (Implant, Endosseous, Orthodontic). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dentaurum, Inc.”.

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 Dentaurum’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentaurum since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Dentaurum

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?