Australia TGA ARTG record

Impression material, dental, silicone

Australia TGA ARTG Registered Device · Smileflex · Zhengzhou Huaer Electro-Optics Technology Co Ltd · Class I · Started August 09, 2021

Good Name: Smileflex - Impression material, dental, silicone

Device classification

Risk Class: Class I
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: August 09, 2021
Effective Date: August 09, 2021

Sponsor

Name: Smileflex

Manufacturer

Name: Zhengzhou Huaer Electro-Optics Technology Co Ltd
Country: China
Address: 11th Floor Block B Building 18 Henan International University Science Park, (East District), Zhengzhou, Henan, 450001

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.

About this record

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 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.