Device Dossier

Hand-held intraoral dental x-ray system, digital

Device Dossier for Hand-held intraoral dental x-ray system, digital (Hand-held intraoral dental x-ray system, digital, Class IIb, sponsor Osstem). ARTG…

Intended purpose

N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

TGA Public Summary