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Stationary panoramic/tomographic dental x-ray system, digital

Access comprehensive regulatory information for Stationary panoramic/tomographic 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 July 18, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Stationary panoramic/tomographic dental x-ray system, digital
Australia TGA ARTG Registered Device
Good Name: Osstem Australia Pty Ltd - Stationary panoramic/tomographic dental x-ray system, digital
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Intended Purpose

Cone-beam computed tomography system (CBCT), T2 PLUS is a variation of traditional computed tomography (CT) systems. T2 PLUS system used by dental professionals rotate around the patient, capturing data using a cone-shaped X-ray beam. These data are used to reconstruct a three-dimensional (3D) image of the following regions of the patientโ€™s anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw, and neck); and ears, nose, and throat (โ€œENTโ€). This may help with the diagnosis, treatment planning and evaluation of certain conditions. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 18, 2024
Effective Date
July 18, 2024
Manufacturer
Country
South Korea
Address
2nd Floor B-dong 51 Mayu-ro 238beong-gil, Siheung-si Gyeonggi-do, 15079