Australia TGA ARTG record

Bite registration device, bite rim

Australia TGA ARTG Registered Device · Kulzer Australia Pty Ltd · Kulzer GmbH · Class IIa · Started January 23, 2024

Good Name: Kulzer Australia Pty Ltd - Bite registration device, bite rim

Device classification

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

Registration information

Start Date: January 23, 2024
Effective Date: January 23, 2024

Sponsor

Name: Kulzer Australia Pty Ltd

Manufacturer

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

Intended purpose

To be used in dentistry for bite registration. Flexitime Bite - Indicated for Standard bite registrations in the end bite position, Portrayal of opposing dentition, Coating of bite forks, Key material for needle point registration, Production of small model segments. Memoreg 2 - Indicated for Standard interoclusal records, location material for intra-oral pin tracing template. Memosil 2 - Indicated for Front, occlusal record, Transfer matrix for brackets (indirect bonding), Fixing of x-ray balls when planning the implants, Matrix-walls (wall thickness max. 6 mm) for laboratory (pre-)pressing and injection technique of Signum veneering composites.

About this record

Access comprehensive regulatory information for Bite registration device, bite rim in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Kulzer Australia Pty Ltd, manufactured by Kulzer GmbH in Germany. The device registration started on January 23, 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.