Dental impression material kit, single-use
Access comprehensive regulatory information for Dental impression material kit, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Denta Forma Pty Ltd, manufactured by Zhengzhou Huaer Electro-Optics Technology Co Ltd in China. The device registration started on May 21, 2024.
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.
A collection of non-sterile devices intended for single patient use suitable for taking dental impressions to obtain a reverse or negative model of the tissues in the mouth. This can be used to attain an imprint of upper and lower teeth (including gums) for the construction of mould to manufacturer a custom-made orthodontic appliance. The kit includes dental impression materials, impression trays and nitrile gloves.