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Dental implant suprastructure device, permanent - ARTG 460086

Access comprehensive regulatory information for Dental implant suprastructure device, permanent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 460086 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 IIb
ARTG 460086
Class IIb
Dental implant suprastructure device, permanent
ARTG ID: 460086
Good Name: Dr K Y Lee Pty Ltd - Dental implant suprastructure device, permanent
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Intended Purpose

Dental abutments are intended to be placed on the fixture and connected to the fixture with screw, such as artificial teeth, and to restore a patient's chewing function.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
460086
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