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Craniofacial bone screw, non-biodegradable - ARTG 480707

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 480707 and sponsored by Nobel Biocare Australia Pty Ltd, manufactured by Osteogenics Biomedical Inc in United States of America. The device registration started on February 24, 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 IIb
ARTG 480707
Class IIb
Craniofacial bone screw, non-biodegradable
ARTG ID: 480707
Good Name: Nobel Biocare Australia Pty Ltd - Craniofacial bone screw, non-biodegradable
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Intended Purpose

The creosโ„ข screw fixation is intended for use in the oral cavity to stabilize, fixate, and support bone grafts, bone filling materials, and barrier membranes. It is specifically designed to aid in the regeneration of bone by providing mechanical support to maintain the positioning and integrity of these materials within the oral anatomical site. This device is indicated for patients requiring bone regeneration support in oral surgical procedures, where the stabilization of bone grafts and/or barriers is essential for successful clinical outcomes.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
480707
Start Date
February 24, 2025
Effective Date
February 24, 2025
Manufacturer
Country
United States of America
Address
4620 71st Street Building 78-79, Lubbock, TX, 79424