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Impression material, dental, silicone - ARTG 372392

Access comprehensive regulatory information for Impression material, dental, silicone in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 372392 and sponsored by Smileflex, manufactured by Zhengzhou Huaer Electro-Optics Technology Co Ltd in China. The device registration started on August 09, 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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Class I
ARTG 372392
Class I
Impression material, dental, silicone
ARTG ID: 372392
Good Name: Smileflex - Impression material, dental, silicone
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Intended Purpose

Elastomeric material based on polysiloxane capable of reacting to form a rubber-like material suitable for taking dental impressions to obtain a reverse or negative model of the tissues in the mouth.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
372392
Start Date
August 09, 2021
Effective Date
August 09, 2021
Sponsor
Manufacturer
Country
China
Address
11th Floor Block B Building 18 Henan International University Science Park, (East District), Zhengzhou, Henan, 450001