Device Dossier

Dental implant suprastructure device, permanent

Device Dossier for Dental implant suprastructure device, permanent (Dental implant suprastructure device, permanent, Class IIa, sponsor Dentsply Sirona).…

Intended purpose

This group contains abutments intended for permanent use. The superstructures are dental components for holding the prosthetic restoration, which are connected to a multi-component system (such as an overdenture abutment, CONNECT abutment or multi-unit abutment), and are connected above the gingival tissue. In addition, this group includes prosthetic screws used to connect screw-retained abutments to the implants or bridge suprastructure. The Prosthetic screw does not penetrate a tooth or enter the gum or bone beyond the tooth. These are single use devices.

TGA Public Summary