Device Dossier

BioRoot Flow - Hygroscopic dental cement

Device Dossier for BioRoot Flow - Hygroscopic dental cement (Hygroscopic dental cement, Class III, sponsor Specialites Septodont). ARTG record, intended…

Intended purpose

Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp in the course of initial treatment or retreatment procedure

Functional description

An implantable medical device intended to be used in dentistry, part of endodontic cements used as permanent root canal sealer. It is a hydrophilic mineral root canal sealer (bioactive cement) based on the reaction of tricalcium silicate with water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is able to induce mineralization and to promote periapical healing.

TGA Public Summary