Device Dossier

Dental implant suprastructure device, permanent

Device Dossier for Dental implant suprastructure device, permanent (Dental implant suprastructure device, permanent, Class IIb, sponsor Henry Schein…

Intended purpose

These prefabricated non-sterile dental devices helps create the necessary suprastructure mimicking preparations of natural teeth and is used during dental implant restorative procedures and will provide the permanent intermediate fixture level between the dental implant and the final restoration (e.g., bridge, single tooth, overdenture). This single-use device can be for, e.g., cement or screw retained restorations and will include, e.g., abutments, titanium base - CAD/CAM for crowns/bridges, cylinders etc..

TGA Public Summary