LEONE S.P.A.

Leone S.p.A. specialises in dental medical devices, including rotary instruments used for drilling, cutting, and shaping teeth during procedures like restorative and endodontic treatments. They also produce dental implants designed for osseointegration in the jawbone, along with implant abutments and related components to support prosthetic restorations such as crowns, bridges, or dentures.

Leone S.p.A. is headquartered in Italy, which means its devices are manufactured and regulated under the European Union’s medical device framework. This includes compliance with EU Medical Device Regulations (MDR) and registration in the EU’s eudamed database, ensuring traceability and transparency for authorised devices within the European Economic Area.

Leone S.p.A.’s devices are listed in the eudamed database, the official EU registry for medical devices authorised for commercialisation within the European Economic Area. This database tracks device details, including manufacturer information, classifications, and regulatory status, ensuring transparency for healthcare professionals and regulators.

Leone S.p.A.’s devices are classified under the EU Medical Device Regulations (MDR) as Class I, Class IIa, or Class IIb, depending on their risk level and intended use. For example, dental rotary instruments may fall into lower-risk classes (e.g., Class I or IIa), while dental implants—due to their direct contact with bone and long-term use—are typically classified as Class IIb, reflecting their higher risk profile and stricter regulatory requirements.