Australia TGA ARTG record

Aoralscan3 - CAD/CAM unit, dental, chairside

Australia TGA ARTG Registered Device · Oceanic Dental Pty Ltd · Shining 3D Tech Co Ltd · Class IIa · Started August 03, 2022

Good Name: Oceanic Dental Pty Ltd - Aoralscan3 - CAD/CAM unit, dental, chairside

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 03, 2022
Effective Date: August 03, 2022

Sponsor

Name: Oceanic Dental Pty Ltd

Manufacturer

Name: Shining 3D Tech Co Ltd
Country: China
Address: No 1398 Xiangbin Road Wenyan Xiaoshan Zhejiang, Hangzhou, 311258

Intended purpose

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

About this record

Access comprehensive regulatory information for Aoralscan3 - CAD/CAM unit, dental, chairside in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Oceanic Dental Pty Ltd, manufactured by Shining 3D Tech Co Ltd in China. The device registration started on August 03, 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.