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Craniofacial bone screw, non-biodegradable - ARTG 458905

Access comprehensive regulatory information for Craniofacial bone screw, non-biodegradable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 458905 and sponsored by Biomedent Pty Ltd, manufactured by Devemed GmbH in Germany. The device registration started on August 08, 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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Class IIb
ARTG 458905
Class IIb
Craniofacial bone screw, non-biodegradable
ARTG ID: 458905
Good Name: Biomedent Pty Ltd - Craniofacial bone screw, non-biodegradable
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Intended Purpose

This is a small surgically invasive fixation screw that is intended to be used fix into craniofacial bone including both the maxilla and/or mandible bone to hold plates to bone or to provide direct interfragmentary stabilization of bone during surgical procedures within the maxilla facial area.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
458905
Start Date
August 08, 2024
Effective Date
August 08, 2024
Manufacturer
Country
Germany
Address
take-off GewerbePark 30, Neuhausen, ob Eck, 78579