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Dental impression material kit, single-use - ARTG 449249

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 registered under ARTG number 449249 and 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.

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TGA ARTG Official Data
Class I
ARTG 449249
Class I
Dental impression material kit, single-use
ARTG ID: 449249
Good Name: Denta Forma Pty Ltd - Dental impression material kit, single-use
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Intended Purpose

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.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
449249
Start Date
May 21, 2024
Effective Date
May 21, 2024
Manufacturer
Country
China
Address
11th Floor Block B Building 18 Henan International University Science Park, (East District), Zhengzhou, Henan, 450001