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Dental appliance fabrication material, resin - ARTG 465867

Access comprehensive regulatory information for Dental appliance fabrication material, resin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 465867 and sponsored by The Weringa Group Pty Ltd, manufactured by Formlabs Ohio dba Spectra Photopolymers in United States of America. The device registration started on October 25, 2024.

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 I
ARTG 465867
Class I
Dental appliance fabrication material, resin
ARTG ID: 465867
Good Name: The Weringa Group Pty Ltd - Dental appliance fabrication material, resin
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Intended Purpose

Formlabs IBT Flex Resin is a photopolymer resin that can be utilized to 3D print dental appliances such as indirect bonding trays to aid in the placement of brackets/attachments in the treatment of occlusal disharmonies and trays for guided restorative techniques to aid in the molding of composite in the treatment of aesthetic or functional disharmonies.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465867
Start Date
October 25, 2024
Effective Date
October 25, 2024
Manufacturer
Country
United States of America
Address
27800 Lemoyne Road Suites L M N & O, Millbury, Ohio, 43447