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.
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.

