WIELAND Edelmetalle GmbH

WIELAND Edelmetalle GmbH specialises in dental medical devices, including titanium alloy implants and components like the GQ Quattro Disc, WHITE NEM EASY Disc, and DENTONEM. They also produce cobalt-chromium milling blanks (e.g., CoCrMo6 and dima Mill CoCr solid) for dental restorations, as well as gold baths (e.g., AGC® Goldbad Comfort) used in dental laboratory processes. These products are designed for dental applications requiring high precision and biocompatibility.

WIELAND Edelmetalle GmbH is based in Germany, which means its devices are subject to EU medical device regulations. Since these products fall under EU Class IIa classification, they must comply with the EU Medical Device Regulation (MDR) or the previous Medical Device Directive (MDD), depending on their conformity date. The company’s devices are registered in the EU’s eudamed database, ensuring transparency and traceability within the European market.

WIELAND Edelmetalle GmbH’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) and allows healthcare professionals, authorities, and patients to verify the legitimacy and compliance status of Class IIa devices marketed in the European Union.

WIELAND Edelmetalle GmbH’s devices are classified as EU Class IIa medical devices. This classification is determined based on their intended use and risk level—dental implants and related components fall into this category due to their moderate risk profile, requiring compliance with specific EU safety, performance, and clinical evaluation requirements before market placement.