Pure Global

Dental appliance fabrication material, resin - ARTG 480365

Access comprehensive regulatory information for Dental appliance fabrication material, resin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 480365 and sponsored by Henry Schein Halas, manufactured by PoliDent doo in Slovenia. The device registration started on February 21, 2025.

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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Class IIa
ARTG 480365
Class IIa
Dental appliance fabrication material, resin
ARTG ID: 480365
Good Name: Henry Schein Halas - Dental appliance fabrication material, resin
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Intended Purpose

PMMA CAD/CAM disc for milling of long-term temporary crowns and bridges, for milling and verifying the appliance on the plaster model/mouth before the final ZrO2 milling process, for milling the removable occlusal splint, and for milling of individual denture teeth, full arch and tooth segments to manufacture denture.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
480365
Start Date
February 21, 2025
Effective Date
February 21, 2025
Manufacturer
Country
Slovenia
Address
Volcja Draga 42, Volcja Draga, 5293