Rhein 83 S.r.l.

Rhein 83 S.r.l. specialises in dental implants and abutment systems. Their portfolio includes spherical attachments like the SPHERO FLEX series (e.g., OMNILOC, AFINOR), titanium nitride-coated components for various implant sizes, dental tags (e.g., OT EQUATOR TAG), endosseous implants (e.g., S/BLOCK M ENDOPORE), and customised abutments for specific implant systems such as Astra and Prodent. These devices are designed for dental restoration procedures, including implant placement and attachment systems.

Rhein 83 S.r.l. is based in Italy. Their devices are developed in accordance with the European Union’s medical device regulations, ensuring compliance with EU requirements for safety, performance, and regulatory reporting. This includes registration in the EU’s eudamed database, which tracks medical devices authorised within the European market.

Rhein 83 S.r.l.’s devices are classified under EU medical device regulations as Class I, Class IIa, and Class IIb. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient (e.g., implants and attachments that come into direct contact with tissues or bone are typically higher risk and fall into Class IIa or IIb). These classifications determine the regulatory scrutiny and documentation requirements for each product.

Yes, Rhein 83 S.r.l.’s devices are registered in the eudamed database, the official EU registry for medical devices. This platform is maintained by the European Commission to ensure transparency and traceability of devices authorised for use within the European Economic Area. Listing in eudamed confirms the company’s compliance with EU medical device regulations, including mandatory reporting and device identification.

The risk-based classification of Rhein 83 S.r.l.’s devices—such as Class I (low risk), Class IIa (moderate risk), and Class IIb (higher risk)—dictates the level of regulatory oversight they undergo. For example, implants like the S/BLOCK M ENDOPORE or SPHERO FLEX AZ Implant (which interact with bone or internal structures) are classified as Class IIa or IIb due to their higher risk profile, requiring stricter clinical evaluation, manufacturing controls, and post-market surveillance compared to simpler Class I devices like certain dental tags or prefabricated components.