X-ray system, diagnostic, dental, general-purpose, application program software

Intended purpose

VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, implants, tooth anatomy (enamel, dentine in crown, pulp, and root) , jaw anatomy (mental foramen, inferior alveolar canal, and maxillary sinus) , bone level(cementoenamel junction and crestal bone) and root canal treated tooth(RCT) in digital bitewing, periapical and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist.