Australia TGA ARTG record

Dental material, <specify>

Australia TGA ARTG Registered Device · Dental Axess Pty Ltd · Good Fit Technologies LLC · Class I · Started October 04, 2023

Good Name: Dental Axess Pty Ltd - Dental material, <specify>

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 04, 2023
Effective Date: October 04, 2023

Sponsor

Name: Dental Axess Pty Ltd

Manufacturer

Name: Good Fit Technologies LLC
Country: United States of America
Address: 100 Cambridge Street Suite 1400, Boston, MA, 02114

Intended purpose

This is a thermoplastics material that is intended to be used to fabricate clear aligner & retainer materials and other molded devices during a dental procedure in the mouth.

About this record

Access comprehensive regulatory information for Dental material, <specify> in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dental Axess Pty Ltd, manufactured by Good Fit Technologies LLC in United States of America. The device registration started on October 04, 2023.

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.