Located close to Milan, Prodent Italia has been designing and producing implant systems since the advent of implantology in Italy.

The Company’s proprietors and management guarantee stability and growth thanks to their focus on research and to the constant support provided to dental surgeries.

Research

To create a new implant, the ideal situation is where three sectors – “clinical”, technical and product – cooperate. Requests and specifications are received from expert dentists who bring with them innovative ideas designed to overcome the limitations encountered in the field.

The “world” of products translates clinical requirements into a design plan; thus the technical sector, composed of bio-engineers, designs the implant system on the basis of requirements concerning the feasibility and biomechanical reliability of the implant, which has to be integrated into the bone and withstand loading forces. Static and dynamic load tests are carried out by Prodent Italia with the support of the LaBS (Laboratory of Biological Structured Mechanics) at Milan Polytechnic.

Certifications

Prodent Italia has implemented a Quality Management System in compliance with UNI CEI EN ISO 13485. Within the scope of the Quality Management System, numerous controls are envisaged and conducted with the aim of assuring an extremely high-quality level for all Prodent Italia products. Before placing each Medical Device on the market, all the necessary tests are carried out to assure that every device is conformed to the relative Safety and Performance Requirements established by current Legislations.

The first System and Product certifications issued to Prodent Italia date back to 1998. Over the years, Prodent Italia has continued to innovate its Medical Devices, which are currently CE marked according to Regulation (EU) 2017/745 and subsequent amendments (also known as MDR – Medical Devices Regulation). In addition, Prodent Italia will continue to place CE marked Medical Devices on the market in compliance with Directive 93/42 EEC and subsequent amendments, in accordance with Article 120 of the MDR and according to the schedule indicated therein.

For all Medical Devices, post-market surveillance, market surveillance and vigilance are carried out as required by MDR.