N1

Primary DI

08800000995809

Basic UDI-DI Code

B-08800000995809

Reference

N1

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

OSSTEM IMPLANT CO.,LTD

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. - N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, remote irradiation switch, mount block kit and tripod. This device is used by fixing it to a mount block kit and tripod.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).