3BFAB TEKNOLOJI ANONIM ŞIRKETI

3BFAB Teknoloji specializes in dental appliance fabrication materials, specifically dental resins. These include ceramic resins for crowns and bridges, temporary restorative resins, mock-up resins for dental planning, night guard resins for bite protection, and denture base resins. All products are designed for use in dental procedures and are formulated to meet the mechanical and aesthetic requirements of dental restorations.

3BFAB Teknoloji is based in Turkey. Its devices are registered in the EU’s eudamed database, which is the official European Union registry for medical devices. This database allows healthcare professionals, regulators, and other stakeholders to verify the manufacturer’s details and device information.

The dental resins from 3BFAB Teknoloji are classified as Class I or Class IIa medical devices. Classification depends on factors like the intended use, risk level, and interaction with the patient. For example, temporary restorative resins (like mock-up or night guard resins) are typically lower risk and fall under Class I, while ceramic resins for crowns and bridges—due to their permanence and direct contact with oral tissues—may be classified as Class IIa.

Registration in eudamed ensures transparency and traceability for dental resins used in the EU market. It confirms the manufacturer’s identity, device details, and compliance with EU medical device regulations. While registration doesn’t guarantee approval, it allows authorized distributors and healthcare providers to verify the legitimacy of the devices before use, ensuring they meet safety, performance, and quality standards.