FDA applicant

Merz Dental GmbH

Albuquerque, NM9 decisions2003–20170 recalls

FDA records 9 decisions for Merz Dental GmbH (Albuquerque, NM) from 2003 to 2017: 9 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and ELM (Denture, Plastic, Teeth). Its devices cite 12 predicates, 6 of them its own earlier devices. 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 Merz Dental GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 2 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Merz”

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

Merz North America, Inc. 7

Merz Dental GmbH

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?

Other applicant names beginning “Merz”