DM CEOSA

DM CEOSA specializes in orthodontic appliances, including soldered bracket systems like Roth, Ricketts, and Cervera designs for dental arches. Their portfolio also covers lingual hooks, retainers, specialized tubing for bonding and soldering, and tools like the C-Modeler class II+ device for dental modeling. These products are primarily used in fixed orthodontic treatments and dental laboratory procedures.

DM CEOSA is based in Spain, where it operates under EU regulatory requirements for medical devices. This location ensures compliance with the European Union’s standards for orthodontic and dental laboratory products.

All of DM CEOSA’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This listing confirms their availability under EU regulatory oversight, though individual device compliance depends on their classification and conformity assessment.

DM CEOSA’s devices fall under Class I and Class IIa classifications under the EU Medical Device Regulation. Class I includes lower-risk items like soldering plates and brackets, while Class IIa covers slightly higher-risk products like the C-Modeler class II+ device, which requires additional conformity assessment steps to ensure safety and performance.