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Fixture/appliance dental drill, reusable - ARTG 460133

Access comprehensive regulatory information for Fixture/appliance dental drill, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 460133 and sponsored by Dr K Y Lee Pty Ltd, manufactured by MegaGen Implant Co Ltd in South Korea. The device registration started on August 20, 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 460133
Class IIa
Fixture/appliance dental drill, reusable
ARTG ID: 460133
Good Name: Dr K Y Lee Pty Ltd - Fixture/appliance dental drill, reusable
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Intended Purpose

Surgical fixture /appliance drill bit intended to be used to for make a hole on the bone and for expanding the hole made to insert fixture.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460133
Start Date
August 20, 2024
Effective Date
August 20, 2024
Manufacturer
Country
South Korea
Address
45 Secheon-ro 7-gil Dasa-eup, Dalseong-gun, Daegu, 42921