Device Dossier

Surgical planning/navigation-enhancement system

Device Dossier for Surgical planning/navigation-enhancement system (Surgical planning/navigation-enhancement system, Class IIa, sponsor Emergo). ARTG…

Intended purpose

The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental surgical procedures. The system provides software to preoperatively plan dental surgical procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous and edentulous adult and geriatric patients who need dental surgery as part of their treatment plan.

TGA Public Summary