Device Dossier

Dental implant suprastructure device, permanent

Device Dossier for Dental implant suprastructure device, permanent (Dental implant suprastructure device, permanent, Class IIb, sponsor Nobel Biocare).…

Intended purpose

These devices are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or immediate abutment support for fixed bridgework. The devices can be used for the attachment of denture prostheses, fixed or removable bridgework, or as a freestanding single tooth replacement. These devices include categories of prosthetics such as: cement retained straight abutments, cement retained angled abutments, screw receiving overdenture abutments, ball abutments, and gold custom cast abutments. These devices are also ancillary components such as: copings, transfers, analogs, healing collars, and surgical cover screws.

TGA Public Summary