Device Dossier
CAD/CAM unit, dental, chairside
Device Dossier for CAD/CAM unit, dental, chairside (CAD/CAM unit, dental, chairside, Class IIa, sponsor Zirkonzahn). ARTG record, intended purpose, GMDN…
- GMDN category: CAD/CAM unit, dental, chairside
Intended purpose
Detection Eye is an intraoral scanner that works with the supplied software programs to perform intraoral scanning directly, as well as digitally acquire and save the 2D/3D colour images of the patient's teeth and gingiva for orthodontic, implant and restoration usage. Detection Eye is an intraoral scanner conceived for use in the dental field. The scanner can be used intraorally on the patient to obtain three-dimensional morphology and colour texture information of soft and hard tissue surfaces such as teeth, gums and mucous membranes, facilitating comfortable data capturing for patients, reducing stress for medical care, and improving efficiency for following processing. The scanner and related software programs are conceived for use in dental clinics, dental hospitals, and dental laboratories. This device is designed and intended for use by persons with professions of dentistry and dental laboratory technology. The device in no way interprets these images nor it provides a medical diagnosis of the patient being examined.