Australia flagARTG 395110

Cone beam computed tomography system, head/neck

ARTG ID: 395110 · Ajax Dental Supplies Pty Ltd · Fussen Technology Co Ltd · Class IIb · Started August 30, 2022

Good Name: Ajax Dental Supplies Pty Ltd - Cone beam computed tomography system, head/neck

Device classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
395110
Start Date
August 30, 2022
Effective Date
August 30, 2022
Sponsor
Manufacturer
Country
China
Address
3F Building #B Minlida Industrial Building Honghualing Industrial Zone, 1189 Liuxian Avenue Pingshan Community Taoyuan Street Nanshang District, Shenzhen, Guangdong, 518055
Intended purpose

This is a stationary device that is intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It is typically intended for dental diagnostic x-ray images. This is an all-in-one dental X-ray unit that produces diagnostic images for panoramic, cephalometric, and CBCT evaluation.

About this record

Access comprehensive regulatory information for Cone beam computed tomography system, head/neck in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 395110 and sponsored by Ajax Dental Supplies Pty Ltd, manufactured by Fussen Technology Co Ltd in China. The device registration started on August 30, 2022.

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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