Australia TGA ARTG record

Resin-composite dental cement

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

Good Name: Andarsyn Pty Ltd - Resin-composite dental cement

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 non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

About this record

Access comprehensive regulatory information for Resin-composite dental cement 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.