Alphadent NV

Alphadent NV specializes in dental devices primarily used in pediatric dentistry and endodontic procedures. Their portfolio includes impression tools and analogues for M3-sized teeth, space maintainers (such as the CEKA M3 and REVAX M2), and post systems for dental restorations. These products are designed to support dental impressions, tooth preservation in children, and restoration procedures, ensuring compatibility with pediatric oral health needs.

Alphadent NV is based in Belgium, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company’s products are marketed within the European Economic Area (EEA), they must comply with the EU Medical Device Regulation (MDR) framework. This includes registration in the EU’s official device database, eudamed, which ensures transparency and traceability for authorized devices.

Alphadent NV’s devices are listed in eudamed, the European Union’s digital registry for medical devices. This registry is mandatory for all medical devices marketed in the EEA, including Class I devices like those produced by Alphadent NV. Listing in eudamed confirms compliance with EU requirements and provides public access to device information, such as manufacturer details and regulatory status.

All of Alphadent NV’s devices fall under EU Medical Device Regulation (MDR) Class I. This classification applies to low-risk devices that pose minimal risk to patients, such as dental impression tools, space maintainers, and post systems. Class I devices must still meet basic safety and performance requirements, but they typically undergo less stringent scrutiny than higher-risk categories, though they remain subject to mandatory registration in eudamed.