Australia TGA ARTG record

Dental impression material preparation dispensing utensil

Australia TGA ARTG Registered Device · Durodent Holdings Pty Ltd · Zhermack SPA · Class I · Started March 21, 2022

Good Name: Durodent Holdings Pty Ltd - Dental impression material preparation dispensing utensil

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 21, 2022
Effective Date: March 21, 2022

Sponsor

Name: Durodent Holdings Pty Ltd

Manufacturer

Name: Zhermack SPA
Country: Italy
Address: Via Bovazecchino, 100 45021 , Badia Polesine

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.

About this record

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 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.