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Dental matrix band kit - ARTG 482051

Access comprehensive regulatory information for Dental matrix band kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482051 and sponsored by Thomsen Dental Pty Ltd, manufactured by Shanghai Ristea Industries Co Ltd in China. The device registration started on March 07, 2025.

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
ARTG 482051
Class I
Dental matrix band kit
ARTG ID: 482051
Good Name: Thomsen Dental Pty Ltd - Dental matrix band kit
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Intended Purpose

A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
482051
Start Date
March 07, 2025
Effective Date
March 07, 2025
Manufacturer
Country
China
Address
Suite C Floor 31 Tower 1 Jiahui Plaza No 2601 Xietu Rd, Shanghai, 200030