Pure Global

Stationary intraoral dental x-ray system, digital - ARTG 468925

Access comprehensive regulatory information for Stationary intraoral dental x-ray system, digital in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 468925 and sponsored by ICONA Pty Ltd, manufactured by XLINE S r l in Italy. The device registration started on November 15, 2024.

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 IIb
ARTG 468925
Class IIb
Stationary intraoral dental x-ray system, digital
ARTG ID: 468925
Good Name: ICONA Pty Ltd - Stationary intraoral dental x-ray system, digital
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Intended Purpose

This is an intraoral dental device that is intended to be used along with the most modern digital radiography systems that will enable excellent image quality for more accurate diagnoses of structures in the mouth during dental procedures. It can be flexibly integrated into any space and has automatic adjustment of exposure times.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
468925
Start Date
November 15, 2024
Effective Date
November 15, 2024
Sponsor
Manufacturer
Country
Italy
Address
Via Victor Hugo 4, Milano, 20123