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Dental coating, tooth-desensitizing, professional - ARTG 475431

Access comprehensive regulatory information for Dental coating, tooth-desensitizing, professional in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 475431 and sponsored by Kulzer Australia Pty Ltd, manufactured by Kulzer GmbH in Germany. The device registration started on January 09, 2025.

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
ARTG 475431
Class IIa
Dental coating, tooth-desensitizing, professional
ARTG ID: 475431
Good Name: Kulzer Australia Pty Ltd - Dental coating, tooth-desensitizing, professional
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Intended Purpose

For the treatment of hypersensitive dentine. This dental material is suitable for patients requiring dental treatment for the following indications with consideration of the contraindications. - To reduce or even eliminate pain in exposed cervical areas not requiring restoration. - To alleviate or prevent dentinal sensitivity after preparation of teeth to receive indirect or direct restorations.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
475431
Start Date
January 09, 2025
Effective Date
January 09, 2025
Manufacturer
Country
Germany
Address
Leipziger Strasse 2, Hanau, 63450