Pure Global

Dental material, <specify> - ARTG 112643

Access comprehensive regulatory information for Dental material, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 112643 and sponsored by Unident Pty Ltd, manufactured by Unident Pty Ltd in Australia. The device registration started on October 20, 2004.

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 112643
Class I
Dental material, <specify>
ARTG ID: 112643
Good Name: Unident Pty Ltd - Dental material, <specify>
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Intended Purpose

This is a thermoformal plastic sheet that is used to model and fabricate PVC splint material, PETG Splint material, temporary dental protheses, temporary crown and bridge, soft EVA (mouthguards) and hips base and custom trays that are placed in a patients mouth on a tempoary basis.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
112643
Start Date
October 20, 2004
Effective Date
October 20, 2004
Sponsor
Manufacturer
Country
Australia
Address
71 Riverside Avenue, WERRIBEE, VIC, 3030