FDA applicant

Coltene, Inc.

Chicago, IL15 decisions1981–20040 recalls

FDA records 15 decisions for Coltene, Inc. (Chicago, IL) from 1981 to 2004: 15 510(k) clearances. Most are in product codes ELW (Material, Impression) and EJJ (Alloy, Amalgam). No recall is linked to its devices.

FDA’s records also spell it “Coltene AG”.

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

FDA decisions per year

No FDA decision for Coltene, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coltene, 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 “Coltene”

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

Coltene/Whaledent, Inc. 41

Coltene, 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 “Coltene”