Device Dossier

DIODE DENTAL LASER SYSTEM - Dental diode laser system

Device Dossier for DIODE DENTAL LASER SYSTEM - Dental diode laser system (Dental diode laser system, Class IIb, sponsor Dr Clear Aligners). ARTG record,…

Intended purpose

Intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. Teeth Whitening: Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: Intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary increase in local blood circulation.

TGA Public Summary