Akzenta International SA

Akzenta International SA specializes in dental medical devices. Their portfolio includes product lines like PURE|ONE, MEDIBASE, PURE PLANET, and STARLINE, which consist of dental materials and equipment designed for clinical use. These devices are tailored for dental procedures and patient care.

Akzenta International SA is headquartered in Switzerland. The company’s location in Switzerland aligns with regulatory standards in the European Union, where its devices are also tracked.

Akzenta International SA’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing ensures transparency and compliance with EU regulatory requirements.

Akzenta International SA’s devices fall under Class I classification in the EU regulatory framework. Class I devices are generally considered low-risk, often involving simple tools or materials like dental consumables, and require specific conformity assessment procedures before market placement.