Device Dossier

Detector, caries, optical

Device Dossier for Detector, caries, optical (Detector, caries, optical, Class IIa, sponsor Kerr). ARTG record, intended purpose, GMDN category —…

Intended purpose

This is a hand held diagnostic device that is intended to be used to aid the detection of open or incipient carious lesions above the gingiva and for monitoring the progress of such lesions. Indications such as Detection of smooth surface caries, Detection of occlusal carries, Detection of proximal caries, Detection of initial caries, Detection of secondary caries and Detection of cracks

TGA Public Summary