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Dental impression material preparation dispensing utensil - ARTG 385941

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 385941 and sponsored by Durodent Holdings Pty Ltd, manufactured by Zhermack SPA in Italy. The device registration started on March 21, 2022.

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 385941
Class I
Dental impression material preparation dispensing utensil
ARTG ID: 385941
Good Name: Durodent Holdings Pty Ltd - Dental impression material preparation dispensing utensil
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Intended Purpose

A hand-held manual device intended for portioning/measuring and dispensing dental impression materials/components (e.g., alginate, silicone, water) at predefined volumes during impression material preparation; it is not intended for dispensing into the mouth (i.e., not an applicator or tray). It is typically in the form of a spoon and/or cup with a pre-defined volume or with portion-graduated markings. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
385941
Start Date
March 21, 2022
Effective Date
March 21, 2022
Manufacturer
Country
Italy
Address
Via Bovazecchino, 100 45021 , Badia Polesine