Pure Global

X-ray system, diagnostic, dental, panoramic/tomographic, application program software

Access comprehensive regulatory information for X-ray system, diagnostic, dental, panoramic/tomographic, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Dentsply Sirona Pty Ltd, manufactured by Dentsply Implants NV in Belgium. The device registration started on May 09, 2017.

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
Class IIa
X-ray system, diagnostic, dental, panoramic/tomographic, application program software
Australia TGA ARTG Registered Device
Good Name: Dentsply Sirona Pty Ltd - X-ray system, diagnostic, dental, panoramic/tomographic, application program software
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Intended Purpose

Simplant is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as a pre-planning software dental implant placement and surgical treatment.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 09, 2017
Effective Date
May 09, 2017
Manufacturer
Country
Belgium
Address
Research Campus 10, Hasselt, 3500