Device Dossier

Dental implant system

Device Dossier for Dental implant system (Dental implant system, Class IIa, sponsor Dentaurum). ARTG record, intended purpose, GMDN category — compiled…

Intended purpose

This is a wash-tray that contains all the rotary instruments and accessory components needed for implantation. They are arranged according to the operation sequence. For optimal orientation there is a colour-coded and laser-labelled plastic clip beside each instrument. The used instruments and accessory components are put back in the corresponding slots directly after each use. The insertion key is which is part of this tray kit is intended to be used to ensure contact-free insertion and can be extended using a drill extension.

TGA Public Summary