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Endodontic obturation material distribution endpiece, reusable

Access comprehensive regulatory information for Endodontic obturation material distribution endpiece, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by KIVEXMEDICAL PTY LTD, manufactured by Mani Inc in Japan. The device registration started on August 10, 2023.

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 IIa
Class IIa
Endodontic obturation material distribution endpiece, reusable
Australia TGA ARTG Registered Device
Good Name: KIVEXMEDICAL PTY LTD - Endodontic obturation material distribution endpiece, reusable
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Intended Purpose

Endodontic obturation material distribution endpiece, reusable A dental endpiece is designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 10, 2023
Effective Date
August 10, 2023
Manufacturer
Country
Japan
Address
8-3 Kiyohara Industrial Park, Utsunomiya, Tochigi, 321-3231