Device Dossier

Dental diode laser system

Device Dossier for Dental diode laser system (Dental diode laser system, Class IIb, sponsor Ultradent). ARTG record, intended purpose, GMDN category —…

Intended purpose

The intended use of the 810+980nm Diode Laser is to remove, ablate and coagulate tissue, mainly used for dental surgical procedures and is marketed as a dental soft tissue surgical product. The main intended users for this particular device are general dentists, oral surgeons, orthodontists performing procedures where tissue needs to be removed, ablated or coagulated.

TGA Public Summary