Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Pacific Dental Specialties Pty Ltd · Osteogenics Biomedical Inc · Class IIb · Started February 27, 2023

Good Name: Pacific Dental Specialties Pty Ltd - Pro-Fix Precision Fixation system - Craniofacial bone screw, non-biodegradable.

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: February 27, 2023
Effective Date: February 27, 2023

Sponsor

Name: Pacific Dental Specialties Pty Ltd

Manufacturer

Name: Osteogenics Biomedical Inc
Country: United States of America
Address: 4620 71st Street Building 78-79, Lubbock, TX, 79424

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.

About this record

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 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.