IMPLANT PROTESIS DENTAL 2004 S.L.

IMPLANT PROTESIS DENTAL 2004 S.L. specializes in dental prosthetic components, specifically cobalt-chromium (CoCr) castable abutments. These abutments are designed for dental restoration procedures and come in engaging and non-engaging designs with varying angles (e.g., 15° or 25°) and diameters (e.g., Ø 3, Ø 4). The focus is on customizable solutions for dental implants.

The company is based in Spain, as indicated by its registered location. This geographic placement aligns with EU regulatory frameworks, which may influence its compliance and reporting processes for medical devices.

The devices produced by IMPLANT PROTESIS DENTAL 2004 S.L. are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and compliance with EU regulatory requirements for devices like their cobalt-chromium castable abutments.

The company’s devices fall into Class I and Class IIb categories under EU medical device regulations. Classification depends on factors like risk level, intended use, and patient contact duration. For example, dental abutments like their CoCr castable components may be classified as Class IIb due to their role in supporting long-term dental restorations, which carry moderate to high risks if they fail.