Pure Global

CAD/CAM unit, dental, chairside

Access comprehensive regulatory information for 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 Osseo Dental, manufactured by Shining 3D Tech Co Ltd in China. The device registration started on November 01, 2021.

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
Class IIa
CAD/CAM unit, dental, chairside
Australia TGA ARTG Registered Device
Good Name: Osseo Dental - CAD/CAM unit, dental, chairside
Pure Global
DJ Fang

DJ Fang

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Intended Purpose

An intraoral scanner used to take a digital 2D and 3D impression of the patient's mouth/teeth. For computer-aided design (CAD) and manufacturing/production (CAM) of dental restorations.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
November 01, 2021
Effective Date
November 01, 2021
Sponsor
Manufacturer
Country
China
Address
No 1398 Xiangbin Road Wenyan Xiaoshan Zhejiang, Hangzhou, 311258