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Dental implant suprastructure device, temporary

Access comprehensive regulatory information for Dental implant suprastructure device, temporary in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Eledent Pty Ltd, manufactured by Dentis Co Ltd in South Korea. The device registration started on April 06, 2023.

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 I
Class I
Dental implant suprastructure device, temporary
Australia TGA ARTG Registered Device
Good Name: Eledent Pty Ltd - Dental implant suprastructure device, temporary
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DJ Fang

DJ Fang

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Intended Purpose

This product is used when a model is produced in order to implant a fixture in an area that is missing a tooth. In order to complete the implantation, an Impression Coping is attached to the fixture to obtain an impression, which is then connected to the Lab Analog to produce a model. Product is for transient use in the oral cavity. This is a non-sterile, single-use device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 06, 2023
Effective Date
April 06, 2023
Sponsor
Manufacturer
Country
South Korea
Address
99 Seongseoseo-ro Dalseo-gu, Daegu