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Rotary/reciprocating endodontic file/rasp, single-use - ARTG 467746

Access comprehensive regulatory information for Rotary/reciprocating endodontic file/rasp, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 467746 and sponsored by Wishmed Pty Ltd, manufactured by Jining Orodeka Medical Equipment Co Ltd in China. The device registration started on November 08, 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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Class IIa
ARTG 467746
Class IIa
Rotary/reciprocating endodontic file/rasp, single-use
ARTG ID: 467746
Good Name: Wishmed Pty Ltd - Rotary/reciprocating endodontic file/rasp, single-use
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Intended Purpose

These are endodontic instruments designed for mechanical debridement of root canals by enlarging them and smoothening the walls through cutting or abrasion. These instruments are attached to rotational and reciprocating dental handpieces prior to the root canal treatment.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467746
Start Date
November 08, 2024
Effective Date
November 08, 2024
Sponsor
Manufacturer
Country
China
Address
West 15 Floor XinchengFazhan East Building Beihu District, Jining, Shandong, 272000