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Dental material application tool, reusable - ARTG 433333

Access comprehensive regulatory information for Dental material application tool, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 433333 and sponsored by PERTH DENTAL SUPPLIES PTY LTD, manufactured by Otto Leibinger GmbH in Germany. The device registration started on January 10, 2024.

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 433333
Class I
Dental material application tool, reusable
ARTG ID: 433333
Good Name: PERTH DENTAL SUPPLIES PTY LTD - Dental material application tool, reusable
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Intended Purpose

A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patientโ€™s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
433333
Start Date
January 10, 2024
Effective Date
January 10, 2024
Manufacturer
Country
Germany
Address
Griesweg 27, Muhlheim, D-78570