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Intraoral optical scanning system

ARTG ID: 482286 · Dentsply Sirona Pty Ltd · Sirona Dental Systems GmbH · Class I · Started March 12, 2025

Good Name: Dentsply Sirona Pty Ltd - Intraoral optical scanning system

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
Sponsor
Manufacturer
Country
Germany
Address
Fabrik Strasse 31, Bensheim, Germany, 64625
Intended purpose

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

About this record

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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