Pure Global

Pro-Fix Precision Fixation system - Craniofacial bone screw, non-biodegradable. - ARTG 405391

Access comprehensive regulatory information for Pro-Fix Precision Fixation system - 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 405391 and sponsored by Pacific Dental Specialties Pty Ltd, manufactured by Osteogenics Biomedical Inc in United States of America. The device registration started on February 27, 2023.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 405391
Class IIb
Pro-Fix Precision Fixation system - Craniofacial bone screw, non-biodegradable.
ARTG ID: 405391
Good Name: Pacific Dental Specialties Pty Ltd - Pro-Fix Precision Fixation system - Craniofacial bone screw, non-biodegradable.
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

This product is used to stabilize, fixate, and/or support bone grafts, bone filling materials, and/or barrier membranes used for the regeneration of bone in the oral cavity.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
405391
Start Date
February 27, 2023
Effective Date
February 27, 2023
Manufacturer
Country
United States of America
Address
4620 71st Street Building 78-79, Lubbock, TX, 79424