Device Dossier

Root ZX3 (RZX3) - Electrosurgical system, general-purpose

Device Dossier for Root ZX3 (RZX3) - Electrosurgical system, general-purpose (Electrosurgical system, general-purpose, Class IIb, sponsor J Morita). ARTG…

Intended purpose

This is a device that is intended to be used in endodontic treatment that in addition to conventional root canal shaping and cleaning methods incorporates high-frequency conduction (HFC) therapy, enabling the cauterization of pulp in initial treatment, cauterization of pulp in retreatment of challenging cases that could not be addressed solely by conventional methods. The hemostatic effect contributes to enhanced apex location precision. HFC can be used to cauterize the pulp in a pulpectomy procedure. Cauterization results in hemostasis and coagulation of the pulp. HFC can be used to cauterize infected tissue and contaminants inside and around the root canal. After cauterization, symptoms are expected to improve due to the natural healing process of the human body.

TGA Public Summary