Australia TGA ARTG record

Dental bonding agent, polymer based

Australia TGA ARTG Registered Device · Andarsyn Pty Ltd · Saremco Dental AG · Class IIa · Started June 20, 2018

Good Name: Andarsyn 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: June 20, 2018
Effective Date: June 20, 2018

Sponsor

Name: Andarsyn Pty Ltd

Manufacturer

Name: Saremco Dental AG
Country: Switzerland
Address: Gewerbestrasse 4, Rebstein, 9445

Intended purpose

A material, primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution. It may also be used as an enamel bonding material.

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 Andarsyn Pty Ltd, manufactured by Saremco Dental AG in Switzerland. The device registration started on June 20, 2018.

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.