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i500, i700 - Intraoral optical scanning system

Australia TGA ARTG Registered Device · Kulzer Australia Pty Ltd · Medit Corp · Class IIa · Started February 16, 2022

Good Name: Kulzer Australia Pty Ltd - i500, i700 - Intraoral optical scanning system

Device classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
February 16, 2022
Effective Date
February 16, 2022
Sponsor
Manufacturer
Country
South Korea
Address
23 Goreyeodae-ro 22-gil, Seongbuk-gu, Seoul, 02855
Intended purpose

A dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. The system produces 3D scans for use in computer assisted design and manufacturing of dental restorations.

About this record

Access comprehensive regulatory information for i500, i700 - Intraoral optical scanning system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Kulzer Australia Pty Ltd, manufactured by Medit Corp in South Korea. The device registration started on February 16, 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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