Australia TGA ARTG record

Impression material, dental, silicone

Australia TGA ARTG Registered Device · Ez Smile Pty Ltd · Zhengzhou Huaer Electro-Optics Technology Co Ltd · Class I · Started April 26, 2017

Good Name: Ez Smile Pty Ltd - Impression material, dental, silicone

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 26, 2017
Effective Date: April 26, 2017

Sponsor

Name: Ez Smile Pty Ltd

Manufacturer

Name: Zhengzhou Huaer Electro-Optics Technology Co Ltd
Country: China
Address: No 79 Zhenghua Road, Jinshui District, Zhengzhou, 450000

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 Ez Smile Pty Ltd, manufactured by Zhengzhou Huaer Electro-Optics Technology Co Ltd in China. The device registration started on April 26, 2017.

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.