President Dental GmbH

President Dental GmbH specializes in dental devices, including zirconia-based multilayer discs used for milling and layering in restorative procedures. These discs come in various sizes (e.g., 98x14, 98x20) and grades (e.g., B1, BL, D3) to suit different clinical applications. Additionally, the company produces endodontic paper points in standard sizes (e.g., 45–80) for root canal treatment.

President Dental GmbH is based in München, Germany. As a German manufacturer, its devices are subject to EU medical device regulations, including mandatory registration in the EUDAMED database. This ensures compliance with EU requirements for traceability and market surveillance, though individual device authorisation depends on their classification and intended use.

President Dental GmbH’s devices are classified under EU medical device classes I and IIa. Classification is determined by risk level and intended use—e.g., zirconia discs for milling are typically Class IIa due to their role in patient treatment, while endodontic paper points may qualify as Class I if they pose minimal risk. Classification impacts regulatory requirements like clinical evaluation and conformity assessment procedures.

Yes, President Dental GmbH’s devices are registered in the EUDAMED database, which is the official EU registry for medical devices. This listing provides transparency on device details, manufacturer information, and regulatory status, though it does not imply individual device approval—only that the manufacturer has fulfilled registration obligations under EU medical device legislation.