Device Dossier

Hygroscopic dental cement

Device Dossier for Hygroscopic dental cement (Hygroscopic dental cement, Class IIa, sponsor Acteon Australia/New Zealand). ARTG record, intended purpose,…

Intended purpose

This is a dental material referred to as a root repair material that is a ready-to-use, premixed bio ceramic material. This material is intended to be used for permanent root canal repair and surgical applications. It is an insoluble, radiopaque and aluminium-free material based on a calcium silicate composition, which requires the presence of water to set and harden. This material is suitable for repair of root perforation, repair of root resorption, root end filling, apexification and pulp capping. This high flow material is also indicated for permanent obturation of the root canal following vital pulp-extirpation, permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings and for use in the single cone and lateral condensation technique.

TGA Public Summary