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Dental impression material preparation dispensing utensil - ARTG 482043

Access comprehensive regulatory information for Dental impression material preparation dispensing utensil in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482043 and sponsored by Dentsply Sirona Pty Ltd, manufactured by Zhermack SPA in Italy. The device registration started on March 07, 2025.

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 I
ARTG 482043
Class I
Dental impression material preparation dispensing utensil
ARTG ID: 482043
Good Name: Dentsply Sirona Pty Ltd - Dental impression material preparation dispensing utensil
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Intended Purpose

This device is intended to dispense dental alginate impression material via a spoon which has a pre-defined volume

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482043
Start Date
March 07, 2025
Effective Date
March 07, 2025
Manufacturer
Country
Italy
Address
Via Bovazecchino, 100 45021 , Badia Polesine