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Bite registration device, bite rim

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Bite registration device, bite rim
Australia TGA ARTG Registered Device
Good Name: Kulzer Australia Pty Ltd - Bite registration device, bite rim
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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.

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
Manufacturer
Country
Germany
Address
Leipziger Strasse 2, Hanau, 63450