Pure Global

Dental material, <specify>

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.

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Class I
Class I
Dental material, <specify>
Australia TGA ARTG Registered Device
Good Name: Dental Axess Pty Ltd - Dental material, <specify>
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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.

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
Manufacturer
Country
United States of America
Address
100 Cambridge Street Suite 1400, Boston, MA, 02114