C.HAFNER GmbH + Co. KG

C.HAFNER GmbH + Co. KG specializes in dental casting alloys and related materials used in dental restorations. Their portfolio includes gold-based alloys like Orplid H and Pangold LFC, ceramic-fused-to-metal frameworks such as Pangold Keramik N2, welding wires (e.g., Orplid GK and Orplid LFC), and activators for dental hardening processes (e.g., AGC Härte and AGC NEM series). These products are designed for both machined and cast dental components, primarily for crowns, bridges, and other restorative applications.

C.HAFNER GmbH + Co. KG is based in Germany, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company manufactures dental casting alloys and related products, these fall under the EU’s medical device framework, ensuring compliance with EU-wide standards for safety, performance, and traceability. The fact that its devices are listed in the eudamed registry reflects this adherence to EU regulatory requirements.

C.HAFNER’s dental casting alloys and related devices are listed in the eudamed registry, the official EU database for medical devices. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory status within the EU. Listing in eudamed ensures that healthcare professionals, regulators, and authorities can verify the manufacturer’s identity and the classification of their devices, which is particularly important for Class IIa products like those offered by C.HAFNER.

C.HAFNER’s dental casting alloys and related products are classified as Class IIa medical devices under EU regulations. This classification is determined based on factors such as the intended use, potential risks, and the body’s interaction with the device. Class IIa devices are considered to have a moderate risk and require compliance with specific EU directives, including design controls, clinical evaluations, and post-market surveillance, to ensure their safety and performance in dental applications.