Australia TGA ARTG record

Denture base resin, thermoplastic

Australia TGA ARTG Registered Device · Omni Melbourne · Graphenano Dental SL · Class IIa · Started March 12, 2021

Good Name: Omni Melbourne - Denture base resin, thermoplastic

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 12, 2021
Effective Date: March 12, 2021

Sponsor

Name: Omni Melbourne

Manufacturer

Name: Graphenano Dental SL
Country: Spain
Address: Poligono Industrial Tactica de Paterna Calle 2 Numero 1, Paterna, 46980

Intended purpose

This is a thermoplastic nano-reinforced biopolymer disc material that is intended to be used manufacture/fabricate permanent dental structures and ideal for CAD/CAM device manufacture used in dental procedures in the mouth.

About this record

Access comprehensive regulatory information for Denture base resin, thermoplastic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Omni Melbourne, manufactured by Graphenano Dental SL in Spain. The device registration started on March 12, 2021.

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.