ARTG 483531Drill, dental, fixture/appliance, single-use
ARTG ID: 483531 · Osstem Australia Pty Ltd · Osstem Implant Co Ltd · Class IIa · Started March 21, 2025
Good Name: Osstem Australia Pty Ltd - Drill, dental, fixture/appliance, single-use
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 483531
- Start Date
- March 21, 2025
- Effective Date
- March 21, 2025
- Country
- South Korea
- Address
- 66-16 Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002
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.
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.