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Denture base resin, thermoplastic - ARTG 421912

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 registered under ARTG number 421912 and sponsored by Innovatio Dental Supplies Pty Ltd, manufactured by Dental Direkt GmbH in Germany. The device registration started on September 15, 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.

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TGA ARTG Official Data
Class IIa
ARTG 421912
Class IIa
Denture base resin, thermoplastic
ARTG ID: 421912
Good Name: Innovatio Dental Supplies Pty Ltd - Denture base resin, thermoplastic
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Intended Purpose

VITA VIONIC BASE DISC HI are pre-colored dental milling blanks made of high-quality, impact-resistant industrially polymeryzed acrylic polymer (PMMA) that features shade stability of denture bases for the CAD/CAM fabrication for removable dentures. VITA VIONIC BASE DISC HI is a thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base). The material i.e. the milling blank, thermoplastic sheet is manipulated by melting and moulding, or computer-aided techniques such as dental CAD/CAM system to form the shape needed for the patient. After application, this material cannot be reused or re-fabricated.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
421912
Start Date
September 15, 2023
Effective Date
September 15, 2023
Manufacturer
Country
Germany
Address
Industriezentrum 106-108, Spenge, 32139