EM EXACT, S.A.

EM Exact, S.A. specialises in dental implant suprastructures, specifically temporary and preformed components intended for single-use applications. These devices are designed to fit specific dental implant systems and include items like short abutment hats and custom connectors used in prosthetic restorations. The focus is on temporary solutions that support the final placement of dental prosthetics.

EM Exact, S.A. is based in Spain, which means its devices are subject to EU medical device regulations. Since the company’s products are listed in the euDaMed database, they comply with the EU’s mandatory registration requirements for medical devices. This ensures transparency and traceability for regulatory oversight, though individual device authorisation depends on their classification and compliance with EU directives.

EM Exact, S.A.’s devices fall into Class I and Class IIb under EU medical device regulations. Classification determines the regulatory pathway and scrutiny level: Class I devices are generally low-risk and require basic compliance, while Class IIb devices involve higher risks (e.g., those with longer-term tissue contact or customisation) and require stricter validation, such as clinical evaluations or conformity assessments. This classification ensures appropriate oversight based on the device’s potential risk to patients.

Yes, all of EM Exact, S.A.’s devices are registered in the euDaMed database, which is the official EU registry for medical devices. Listing in euDaMed confirms that the manufacturer has fulfilled the EU’s mandatory registration requirements, demonstrating compliance with regulatory obligations such as device classification, technical documentation, and traceability. This transparency is essential for healthcare professionals, distributors, and authorities to verify the legitimacy and compliance status of the devices.