Our company Elitè Medica is part of a holding specialized in the manufacturing of medical products. Elite Medica is dedicated to dentistry field. Our holding companies have been active on the market of high-tech medical products for over 30 years. Our major Company is the exclusive supplier of ETHICON Company. It manufactures plastic products and components for the fields of Surgical and Medical Devices.
Elitè Medica produces dental implants by optimizing all the stages of the production process in such a way as to minimize costs and keep a high quality level of the resulting products, by guaranteeing and certifying all of our products in compliance with the requested standards.
Our Technical Support Service assists our customers in the design prototyping, design and development of the products and of the equipment needed to machine them. Thanks to our expertise in FEM-based structural calculus, we can check the in-use performance of the products, by assessing their strain, stress and other parameters. Our Design Process relies on CAD-CAM tools, which facilitate the manufacturing of fixtures, abutments, rotating instruments and of related equipment, which are manufactured in our major factory by numerical control machines.
Our Planning System (MRP) continually monitors our production process, enabling us to set firm delivery dates.
Our stock of manufacturing machines is constantly upgraded and by testing their operation parameters we can ensure continuous monitoring of the production process in accordance with the ISO 9001 Standard.
Our Production Department can guarantee the manufacturing process and all the checks, tests and inspections set forth in the requested legislation and standards by implementing the procedures specified in the production plains.
The factory is divided in various Departments:
Design Department: The Engineer design and develop new implantologycal products.
Manufacturing Department: all the productive cycles are in compliance with the International Standards UNI EN ISO 9001:2000 - UNI EN ISO 13485:2004. Standards for the design and production of Medical Devices to assure high final qualities to the product.
Quality Department: every productive lot is scrupulously checked to verify the perfect dimensions and the correct connection between implant and prosthetic components. Samples of each productive lot are preserved in the quality room to avoid any control of their properties by sanitary authorities.
Decontamination Department: the products are cleaned and decontaminated in this area. Every process is executed according to strict certified standards which guarantee the total elimination of all the polluting substances. The implants are inserted in the phials closed by plastic caps. All the dental plants rest in a Titanium cylinder where is also positioned the cover screw.
- Sterilization: The implants' boxes are sent to an external authorized Company for the Sterilization by rays irradiation (25 kGy) in complying with the Standards UNI EN 552.