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Drill, dental, fixture/appliance, single-use - ARTG 483531

Access comprehensive regulatory information for Drill, dental, fixture/appliance, 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 483531 and sponsored by Osstem Australia Pty Ltd, manufactured by Osstem Implant Co Ltd in South Korea. The device registration started on March 21, 2025.

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 483531
Class IIa
Drill, dental, fixture/appliance, single-use
ARTG ID: 483531
Good Name: Osstem Australia Pty Ltd - Drill, dental, fixture/appliance, single-use
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Intended Purpose

Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
483531
Start Date
March 21, 2025
Effective Date
March 21, 2025
Manufacturer
Country
South Korea
Address
66-16 Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002