Pure Global

Aoralscan - CAD/CAM unit, dental, chairside - ARTG 480925

Access comprehensive regulatory information for Aoralscan - CAD/CAM unit, dental, chairside in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 480925 and sponsored by Henry Schein Halas, manufactured by Shining 3D Tech Co Ltd in China. The device registration started on February 26, 2025.

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 IIa
ARTG 480925
Class IIa
Aoralscan - CAD/CAM unit, dental, chairside
ARTG ID: 480925
Good Name: Henry Schein Halas - Aoralscan - CAD/CAM unit, dental, chairside
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Intended Purpose

This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
480925
Start Date
February 26, 2025
Effective Date
February 26, 2025
Manufacturer
Country
China
Address
No 1398 Xiangbin Road Wenyan Xiaoshan Zhejiang, Hangzhou, 311258