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Impression material, dental, silicone

Access comprehensive regulatory information for Impression material, dental, silicone in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Henry Schein Halas, manufactured by Dent4You AG in Switzerland. The device registration started on May 29, 2024.

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 I
Class I
Impression material, dental, silicone
Australia TGA ARTG Registered Device
Good Name: Henry Schein Halas - Impression material, dental, silicone
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Intended Purpose

AFFINIS is intended for the recording of the current physical situation in a patientโ€™s mouth (โ€œdental impression materialโ€) for the purpose of repairing, reshaping or replacing the patient's teeth.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 29, 2024
Effective Date
May 29, 2024
Manufacturer
Country
Switzerland
Address
Bahnhofstrasse 2, Heerbrugg, CH-9435