Device Dossier

Intraoral optical scanning system

Device Dossier for Intraoral optical scanning system (Intraoral optical scanning system, Class IIa, sponsor Medical Equipment). ARTG record, intended…

Intended purpose

Intraoral optical scanning system is an optical device used to capture 3D digital impressions (topographical characteristics) of teeth, gingiva, and surrounding oral structures. The data is used for computer-aided design and manufacturing of dental restorations (e.g., crowns, bridges) and orthodontic appliances. These devices are typically hand-held, non-sterile, and used by qualified dental professionals.

TGA Public Summary