Device Dossier

Dental x-ray image interpretive software

Device Dossier for Dental x-ray image interpretive software (Dental x-ray image interpretive software, Class IIa, sponsor Compliance Management…

Intended purpose

Adravision 5handed is a Software as a Medical Device (SaMD) intended to aid in the measurement of mesial and distal bone levels associated with each tooth on all types of 2D dental radiographs as well as detection of pathological (caries, periapical radiolucency and calculus) and/or non- pathological (fillings (metal and non-metal), crown, root canal, bridge, and implant) dental features associated with each tooth on bitewing, periapical and panoramic dental radiographs of permanent teeth in patients 18 years of age or older.

TGA Public Summary