Australia TGA ARTG record

Rubber dam kit

Australia TGA ARTG Registered Device · Kulzer Australia Pty Ltd · Kulzer GmbH · Class I · Started January 22, 2024

Good Name: Kulzer Australia Pty Ltd - Rubber dam kit

Device classification

Risk Class: Class I
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: January 22, 2024
Effective Date: January 22, 2024

Sponsor

Name: Kulzer Australia Pty Ltd

Manufacturer

Name: Kulzer GmbH
Country: Germany
Address: Leipziger Strasse 2, Hanau, 63450

Intended purpose

Kit including rubber dam, frame, clamps and clamp forceps used for fixation of a rubber dam, which is indicated to prevent saliva from interfering with the dental work (e.g. contamination of oral microorganisms during root canal therapy, or to keep filling materials such as composite dry during placement and curing), and to prevent instruments and materials from being inhaled, swallowed or damaging the mouth.

About this record

Access comprehensive regulatory information for Rubber dam kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Kulzer Australia Pty Ltd, manufactured by Kulzer GmbH in Germany. The device registration started on January 22, 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.