Pure Global

Impression material, dental, silicone - ARTG 288319

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 288319 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 288319
Class I
Impression material, dental, silicone
ARTG ID: 288319
Good Name: Ez Smile Pty Ltd - Impression material, dental, silicone
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
288319
Start Date
April 26, 2017
Effective Date
April 26, 2017
Sponsor
Manufacturer
Country
China
Address
No 79 Zhenghua Road, Jinshui District, Zhengzhou, 450000