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.
Production process
The manufacturing process starts with numerically-controlled lathes that produce the devices on special production lines (for implants, prosthetic components and instruments) and continues with 100% products dimensional-control (a rare thing in this sector).
In the case of implants, the surfaces are then subjected to a double etching process (acidification), that assures a typical roughness of the surface of modern conception, and decontaminated
in Argon plasma cleaners. This is followed by their packaging in a clean room, their sterilization using gamma rays and a further secondary packaging.
Furthermore, assessment tests are regularly conducted on the products, to confirm the validity of various production processes adopted and previously validated in compliance with the reference regulations.
Distribution
Prodent Italia distributes its products directly through its own sales network covering the entire country.
Our sales agents are all product specialists and are thus capable of providing dental surgeries with the support they require regarding the various aspects of implants.
This means efficiency in handling implant materials, together with the provision of immediate advice concerning the management of various different clinical cases.
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.
Certificates
SYSTEM CERTIFICATE
UNI CEI EN ISO 13485 Certificate >
PRODUCT CERTIFICATES
CERTIFICATES IN ACCORDANCE TO MDR – Regulation (EU) 2017/745 and subsequent amendments
EU Certificate- Dental Endosseous Implants, Prosthetic Components and Instruments
EU Certificate – Reusable Surgical Instruments
CERTIFICATES IN ACCORDANCE TO MDD – Directive 93/42/EEC and subsequent amendments
EU Certificate – Dental Endosseous Implants
Product specialist
In addition to sales agents, Prodent Italia also provides its customers with support from technical personnel with specific experience in the problems associated with dental implants, who assist the dental surgery in the most complex of cases.
Personalized prosthesis solutions.
Planet Prodent is the CAD/CAM system for personalized prosthetic solutions starting from a modelling file.
Clinical and other training
Prodent Italia knows that the modern-day dental surgery requires continuous clinical and professional updating: thus it regularly organizes training events and courses, throughout the country, both in the clinical context and in the area of surgery management.
Personalized commercial terms
Commercial agreements with a low minimum number of implants, and fixed discounts for the entire duration of the agreement.
