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Dental bonding agent, polymer based

Australia TGA ARTG Registered Device · Healthware Aus Pty Ltd · Silmet Ltd · Class IIa · Started July 15, 2021

Good Name: Healthware Aus Pty Ltd - Dental bonding agent, polymer based

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
July 15, 2021
Effective Date
July 15, 2021
Sponsor
Manufacturer
Country
Israel
Address
12 Hassadna Street Industrial Park, OR-YEHUDA, 6022011
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.

About this record

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 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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