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Intraoral optical scanning system - ARTG 482286

Access comprehensive regulatory information for Intraoral optical scanning system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482286 and sponsored by Dentsply Sirona Pty Ltd, manufactured by Sirona Dental Systems GmbH in Germany. The device registration started on March 12, 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 I
ARTG 482286
Class I
Intraoral optical scanning system
ARTG ID: 482286
Good Name: Dentsply Sirona Pty Ltd - Intraoral optical scanning system
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Intended Purpose

Primescan 2 Cart is intended to be used as an accessory for an intraoral scanner.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482286
Start Date
March 12, 2025
Effective Date
March 12, 2025
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625