Quality does not compromise.

In 1998, the company obtained certification under the UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards for its Quality Management System. That same year, with the entry into force of Directive 93/42/EEC, all medical devices manufactured by the company received the CE marking. In 2018, the company obtained certification for the MDSAP (Medical Device Single Audit Program). In 2026, it obtained MDR Regulation 2017/745 certification for the medical devices in the PMMA Discs and PMMA Cubes product families.

It is currently certified for the Quality Management System in accordance with the UNI CEI EN ISO 13485:2021 standard and for MDSAP ISO 13485:2016 based on the regulatory requirements applicable to medical devices as defined by the authorities in Canada, Brazil, and the U.S. for the following activities: Design and manufacture of: acrylic teeth, PMMA discs, monomers and polymers for bridges and crowns and dental technology, dental impression materials, and distribution of dental devices.

The CE Certificate, issued in accordance with Directive 93/42/EEC and its subsequent amendment, Directive 2007/47/EC—which is currently in force for all medical devices—was issued by the Notified Body Kiwa Cermet Italia.

The EU Certificate of Conformity to Regulation 2017/745, currently in effect, for medical devices in the PMMA Discs and PMMA Cube product families

Biocompatibility Statement - IT Disks