Pure Global

Dental treatment application software - ARTG 481226

Access comprehensive regulatory information for Dental treatment application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 481226 and sponsored by Freyr Australia Pty Ltd, manufactured by DGNCT LLC in United States of America. The device registration started on February 28, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 481226
Class IIa
Dental treatment application software
ARTG ID: 481226
Good Name: Freyr Australia Pty Ltd - Dental treatment application software
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Segmentron Implant is a software device intended for guided implant surgery planning. It is intended for use as a pre-operative planning software for the placement of dental implant(s) based on imported CBTC image data, aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Segmentron Implant is intended to be used only by dental professionals and surgical dentists who are skilled in implant dentistry

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481226
Start Date
February 28, 2025
Effective Date
February 28, 2025
Manufacturer
Country
United States of America
Address
333 SE 2nd Avenue 20th Floor #563, Miami, Florida, 33131