FDA applicant

Wieland Edelmetalle GmbH & Co.

Pforzheim, DE14 decisions2000–20020 recalls

FDA records 14 decisions for Wieland Edelmetalle GmbH & Co. (Pforzheim, DE) from 2000 to 2002: 14 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EJS (Alloy, Other Noble Metal). Its devices cite 13 predicates, 1 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 Wieland Edelmetalle GmbH & Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wieland Edelmetalle GmbH & Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Wieland Edelmetalle GmbH & Co.’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 “Wieland”

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

Wieland Dental + Technik GmbH & Co. KG 45

Wieland Edelmetalle GmbH & Co.

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 “Wieland”