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 PharmaDEV Consulting). ARTG…

Intended purpose

Second Opinion® is a computer aided detection ("CADe") software to identify and mark regions in relation to suspected dental findings which include Caries, Bone Loss, Discrepancy at the margin of an existing restoration, Calculus, Periapical radiolucency, Widened Periodontal Ligament, Crown (metal, including zirconia & non-metal), Filling (metal & non-metal), Root Canal, Bridge and Implants. For pediatric patients (ages 4-11), Second Opinion® is intended only for the detection of caries. It is designed to aid dental health professionals as a second reader in the review of: Bitewing and periapical radiographs for patients 4 years and older with primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs, and Bitewing, periapical, and panoramic radiographs of permanent teeth in patients 12 years of age or older.

TGA Public Summary