Australia TGA ARTG record

Denture base resin, cured

Australia TGA ARTG Registered Device · Henry Schein Halas · Formlabs Ohio dba Spectra Photopolymers · Class I · Started January 23, 2020

Good Name: Henry Schein Halas - Denture base resin, cured

Device classification

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

Registration information

Start Date: January 23, 2020
Effective Date: January 23, 2020

Sponsor

Name: Henry Schein Halas

Manufacturer

Name: Formlabs Ohio dba Spectra Photopolymers
Country: United States of America
Address: 27800 Lemoyne Road Suites L M N & O, Millbury, Ohio, 43447

Intended purpose

A polymerizable resin that that is intended to be used to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard); it may also be used to fabricate, by additive manufacturing, endosseous dental implant accessories, for the manufacture of 3D printed parts used in the production of dental surgical guides, or to manufacture a non-patient worn devices (e.g., drilling templates using 3-D printing). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device as after application the same material cannot be refabricated.

About this record

Access comprehensive regulatory information for Denture base resin, cured in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Henry Schein Halas, manufactured by Formlabs Ohio dba Spectra Photopolymers in United States of America. The device registration started on January 23, 2020.

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.