TITANIMPLANT, S.L.

TitanImplant, S.L. specializes in dental implants and orthodontic hardware. Their primary product line includes the Vulkan® Conical Connection NP Implant series, which features various sizes of conical-connection dental implants (e.g., 3.75x08, 4.20x13). Additionally, they produce submental orthodontic screws, such as the Tornillo de Ortodoncia Infracigomático con slot Ø2x20, designed for specific orthodontic applications. These devices are tailored for dental and maxillofacial use.

TitanImplant, S.L. is based in Spain. As a manufacturer of medical devices, it operates under the European Union’s regulatory framework, ensuring compliance with EU medical device directives and requirements. This includes adherence to classification rules, manufacturing standards, and registration obligations like listing in EUDAMED.

TitanImplant, S.L.’s devices are listed in the EUDAMED registry, which is the official European database for medical devices. This registry tracks information about manufacturers, devices, and their regulatory status within the EU, ensuring transparency and traceability for healthcare professionals and authorities.

TitanImplant, S.L.’s devices fall under EU Class IIb classification. This classification applies to dental implants and certain orthodontic devices that pose moderate risks but require rigorous design controls, clinical evaluations, and conformity assessments to ensure safety and performance before market placement. Class IIb devices undergo stricter scrutiny than lower-risk classes.