Device Dossier

Dental cement, composite, temporary

Device Dossier for Dental cement, composite, temporary (Dental cement, composite, temporary, Class IIa, sponsor Independent Dental Supplies). ARTG…

Intended purpose

A non-aqueous, eugenol-free substance typically containing a mixture of zinc (Zn), magnesium (Mg), and calcium oxide (CaO), or hydroxides with fatty acids, that cures upon the acid/base reaction of its components and is used for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

TGA Public Summary