Australia TGA ARTG record

Hand-held intraoral dental x-ray system, digital

Australia TGA ARTG Registered Device · Osstem Australia Pty Ltd · Osstem Implant Co Ltd · Class IIb · Started April 23, 2024

Good Name: Osstem Australia Pty Ltd - Hand-held intraoral dental x-ray system, digital

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 23, 2024
Effective Date: April 23, 2024

Sponsor

Name: Osstem Australia Pty Ltd

Manufacturer

Name: Osstem Implant Co Ltd
Country: South Korea
Address: 2nd Floor B-dong 51 Mayu-ro 238beong-gil, Siheung-si Gyeonggi-do, 15079

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.

About this record

Access comprehensive regulatory information for Hand-held intraoral dental x-ray system, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Osstem Australia Pty Ltd, manufactured by Osstem Implant Co Ltd in South Korea. The device registration started on April 23, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.