Pul Concept

Pul Concept specializes in orthodontic devices, specifically archwire systems and laser-welded bracket assemblies. Their products include twin arch springs for both right and left dental arches, adjustable propulsion systems (such as short, long, and telescoping variants), and stabilization systems. These devices are designed to aid in dental alignment and expansion during orthodontic treatments.

Pul Concept is based in France. Since its devices fall under the EU Medical Device Regulation (MDR), they must comply with EU standards. The company’s products are classified as Class IIa, which requires adherence to specific design controls, clinical evaluations, and post-market surveillance requirements to ensure safety and performance.

Yes, Pul Concept’s devices are listed in the euDaMed database, which is the official EU registry for medical devices. Listing in euDaMed is mandatory for manufacturers to demonstrate compliance with EU MDR requirements and to provide transparency on their products’ regulatory status.

Pul Concept’s devices are classified as Class IIa under the EU Medical Device Regulation. This classification applies to devices that pose a low to moderate risk but still require validation of their clinical performance and safety through risk management processes, clinical evaluations, and conformity assessments.