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Impression material, dental, silicone - ARTG 319994

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 319994 and sponsored by Pacific Medical Devices, manufactured by Shandong Huge Dental Material Corporation in China. The device registration started on July 11, 2019.

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 319994
Class I
Impression material, dental, silicone
ARTG ID: 319994
Good Name: Pacific Medical Devices - Impression material, dental, silicone
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Intended Purpose

The product is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
319994
Start Date
July 11, 2019
Effective Date
July 11, 2019
Manufacturer
Country
China
Address
No 68 Shanhai Road Donggang District Rizhao City, Shandong Province, 276800