Australia TGA ARTG record

Dental material application tool, reusable

Australia TGA ARTG Registered Device · PERTH DENTAL SUPPLIES PTY LTD · Otto Leibinger GmbH · Class I · Started January 10, 2024

Good Name: PERTH DENTAL SUPPLIES PTY LTD - Dental material application tool, reusable

Device classification

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

Registration information

Start Date: January 10, 2024
Effective Date: January 10, 2024

Sponsor

Name: PERTH DENTAL SUPPLIES PTY LTD

Manufacturer

Name: Otto Leibinger GmbH
Country: Germany
Address: Griesweg 27, Muhlheim, D-78570

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 patient’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.

About this record

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 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.