Device Dossier

Dental examination kit

Device Dossier for Dental examination kit (Dental examination kit, Class IIa, sponsor CGA Trading). ARTG record, intended purpose, GMDN category —…

Intended purpose

This is a dental supply kit that consists of various dental instruments and the necessary materials intended to perform the dental examination. The kit will be supplied to dental clinics in Australia and includes: saliva ejector, bib, tissue, apron, plastic cup, and face mask. It does not contain any pharmaceuticals and is not intended for surgical procedures. The whole is designed for single use only.

TGA Public Summary