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Dental appliance fabrication material, resin - ARTG 465891

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 465891 and sponsored by Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust, manufactured by Biofunctional Materials LLC 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 465891
Class I
Dental appliance fabrication material, resin
ARTG ID: 465891
Good Name: Daronez Pty Ltd T/A Pro Smile Designer ATF The J & R Scollo Family Trust - Dental appliance fabrication material, resin
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Intended Purpose

This is a polymer fabricated material that is used temporarily / short term that is intended to be used by dental technicians and dentists in the fabrication of substructures or frameworks that provide additional mechanical resistance for partially or totally edentulous restorations during dental procedures in the mouth.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
465891
Start Date
October 25, 2024
Effective Date
October 25, 2024
Manufacturer
Country
United States of America
Address
1181 S Rogers Circle Suite 32, Boca Raton, Florida, 33487