FDA applicant

Coltene/Whaledent, Inc.

Mahwah, NJ41 decisions1991–20220 recalls

FDA records 41 decisions for Coltene/Whaledent, Inc. (Mahwah, NJ) from 1991 to 2022: 41 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Coltene/Whaledent AG”, “Coltene/Whaledent GmbH & Co. KG”, “Coltene/Whaledent”, “Coltène/Whaledent 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/Whaledent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Coltene/Whaledent, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Coltene/Whaledent”

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

Coltene, Inc. 15

Coltene/Whaledent, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Coltene/Whaledent”