Device Dossier

Stationary intraoral dental x-ray system, digital

Device Dossier for Stationary intraoral dental x-ray system, digital (Stationary intraoral dental x-ray system, digital, Class IIb, sponsor Nobel…

Intended purpose

This is a diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail.

TGA Public Summary