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Dental material, glazing/hardening - ARTG 458137

Access comprehensive regulatory information for Dental material, glazing/hardening in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 458137 and sponsored by Collective Mode Pty Ltd, manufactured by The Belport Company Inc dba Gingi-Pak in United States of America. The device registration started on August 01, 2024.

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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TGA ARTG Official Data
Class IIa
ARTG 458137
Class IIa
Dental material, glazing/hardening
ARTG ID: 458137
Good Name: Collective Mode Pty Ltd - Dental material, glazing/hardening
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Intended Purpose

This device is designed to be used to seal, coat and glaze the surface of dental acrylic or composite based dental restorations. The setting reaction is based on the self, light, or dual-cured polymerization of an unfilled resin.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
458137
Start Date
August 01, 2024
Effective Date
August 01, 2024
Manufacturer
Country
United States of America
Address
4825 Calle Alto, Camarillo, California, 93012