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Dental bonding agent, polymer based - ARTG 371113

Access comprehensive regulatory information for Dental bonding agent, polymer based in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 371113 and sponsored by Healthware Aus Pty Ltd, manufactured by Silmet Ltd in Israel. The device registration started on July 15, 2021.

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 IIa
ARTG 371113
Class IIa
Dental bonding agent, polymer based
ARTG ID: 371113
Good Name: Healthware Aus Pty Ltd - Dental bonding agent, polymer based
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Intended Purpose

An unfilled resin used to assist the mechanical adhesion of a composite restorative material to etched enamel. Bonding of direct/indirect restorations for all cavity classes using light-curing, dual-curing, or self-curing methacrylate-based composites/compomers. Bonding of fissure sealants. Enamel etching and enamel/dentine etching prior to the adhesive bonding.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
371113
Start Date
July 15, 2021
Effective Date
July 15, 2021
Manufacturer
Country
Israel
Address
12 Hassadna Street Industrial Park, OR-YEHUDA, 6022011