Australia TGA ARTG record

Denture base resin, thermoplastic

Australia TGA ARTG Registered Device · Henry Schein Halas · Dental Direkt GmbH · Class IIa · Started July 26, 2023

Good Name: Henry Schein Halas - Denture base resin, thermoplastic

Device classification

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

Registration information

Start Date: July 26, 2023
Effective Date: July 26, 2023

Sponsor

Name: Henry Schein Halas

Manufacturer

Name: Dental Direkt GmbH
Country: Germany
Address: Industriezentrum 106-108, Spenge, 32139

Intended purpose

These millable blanks (VITA VIONIC BASE DISC HI) are made of a high-quality, industrially polymerized acrylic polymer that features shade stability and are intended for the CAD/CAM fabrication of removable dentures.

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 Henry Schein Halas, manufactured by Dental Direkt GmbH in Germany. The device registration started on July 26, 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.