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Spreader, endodontic, hand-held - ARTG 376440

Access comprehensive regulatory information for Spreader, endodontic, hand-held in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 376440 and sponsored by KIVEXMEDICAL PTY LTD, manufactured by Mani Inc in Japan. The device registration started on October 15, 2021.

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 376440
Class I
Spreader, endodontic, hand-held
ARTG ID: 376440
Good Name: KIVEXMEDICAL PTY LTD - Spreader, endodontic, hand-held
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Intended Purpose

Spreaders are used to laterally condense gutta-percha points during root canal therapy.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
376440
Start Date
October 15, 2021
Effective Date
October 15, 2021
Manufacturer
Country
Japan
Address
8-3 Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231