Australia TGA ARTG record

Impression material, dental, silicone

Australia TGA ARTG Registered Device · Wonder Smile Pty Ltd · Shandong Huge Dental Material Corporation · Class I · Started April 30, 2020

Good Name: Wonder 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 30, 2020
Effective Date: April 30, 2020

Sponsor

Name: Wonder Smile Pty Ltd

Manufacturer

Name: Shandong Huge Dental Material Corporation
Country: China
Address: No 68 Shanhai Road Donggang District Rizhao City, Shandong Province, 276800

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 Wonder Smile Pty Ltd, manufactured by Shandong Huge Dental Material Corporation in China. The device registration started on April 30, 2020.

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.