Device Dossier

Dental implant suprastructure device, temporary

Device Dossier for Dental implant suprastructure device, temporary (Dental implant suprastructure device, temporary, Class IIa, sponsor Dental Devices).…

Intended purpose

a Prefabricated device used to create the necessary superstrucutre mimicking preparations of natural teeth. It is used during dental implant restorative and laboratory procedures to provide a base (the intermediate fixture level) for a temporary restoration during the healing and sculpturing period of the soft tissue prior to the fabrication and installation of the final restoration including bridge, single tooth, overdenture, bars, PMMA bridges, locators, connect abutments etc. This device will include eg brunout cylinders, temporary cylinders, fixture impression pick-ups, replica devices, caps, which come in a variety of shapes, sizes and different materials. This is single use device according to manufacturer publications.

TGA Public Summary