Device Dossier

Dental crown, preformed, temporary

Device Dossier for Dental crown, preformed, temporary (Dental crown, preformed, temporary, Class IIa, sponsor Henry Schein Halas). ARTG record, intended…

Intended purpose

These preformed crowns are specifically intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown and /or is also intended for use as a functional restoration until a permanent crown is fabricated. The device may also be used as a functional restoration for a badly decayed deciduous tooth until the permanant tooth erupts.

TGA Public Summary