Australia TGA ARTG record

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

Australia TGA ARTG Registered Device · Dentsply Sirona Pty Ltd · Dentsply Implants NV · Class IIa · Started May 09, 2017

Good Name: Dentsply Sirona Pty Ltd - X-ray system, diagnostic, dental, panoramic/tomographic, application program software

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

Sponsor

Name: Dentsply Sirona Pty Ltd

Manufacturer

Name: Dentsply Implants NV
Country: Belgium
Address: Research Campus 10, Hasselt, 3500

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.

About this record

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.