Pure Global

Dental bonding agent, polymer based

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
Dental bonding agent, polymer based
Australia TGA ARTG Registered Device
Good Name: Andarsyn Pty Ltd - Dental bonding agent, polymer based
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

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
Manufacturer
Country
Switzerland
Address
Gewerbestrasse 4, Rebstein, 9445