Our customers’ expectations are high, but ours are even higher. Leone products are fabricated in a technologically-advanced manufacturing plant and are subjected to frequent quality checkpoints throughout this process, including visual, strength, stability, and functionality controls. Nearly 10% of the Leone staff accounts for quality control technicians, ensuring quality is our standard.
LeoneAmerica products are manufactured and processed within the framework of a Quality Management System conforming to UNI EN ISO 9001, additional requirements of ISO 13485 and according to the FDA Code of Federal Regulations (CFR) 21 Part 820 provisions.
Leone products are intended exclusively for orthodontic, implantology, and dental use, and should only be used by skilled and/or licensed professionals, who will be held solely responsible for the construction and application of prostheses, partially or fully fabricated with the products manufactured and distributed by Leone and LeoneAmerica. For a proper usage of these devices or products, it is recommended to use them in conjunction with other original Leone products, accessories, and instruments.
With the exception of instruments, all products are designed and manufactured for single use only. After removal from the patient’s mouth, products must be disposed of properly, and according to the laws of the jurisdiction in which they were used. We accept no responsibility for any damage, injury, or other damages caused by reuse of declare single-use products. In the event of multi-use products, decontamination and sterilization must occur for products that have come into contact with another patient.
The effects of metallic orthodontic and implantology devices should be carefully monitored during MRI (Magnetic Resonance Imaging). It is recommended to instruct the patient to report in advance the presence of any type of device or dental materials to the radiology staff in charge of the MRI. Ceramic and polymeric products (with the exception of certain articles containing medical grade Barium) are not radiopaque.