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Surgical procedure kit, dental, non-medicated, reusable - ARTG 474085

Access comprehensive regulatory information for Surgical procedure kit, dental, non-medicated, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 474085 and sponsored by Osstem Australia Pty Ltd, manufactured by Osstem Implant Co Ltd in South Korea. The device registration started on December 19, 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 IIa
ARTG 474085
Class IIa
Surgical procedure kit, dental, non-medicated, reusable
ARTG ID: 474085
Good Name: Osstem Australia Pty Ltd - Surgical procedure kit, dental, non-medicated, reusable
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Intended Purpose

A collection of various dental and prosthetic instruments necessary to perform a dental implant and prosthetic surgical procedure.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
474085
Start Date
December 19, 2024
Effective Date
December 19, 2024
Manufacturer
Country
South Korea
Address
66-16 Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002