Pure Global

Dentis Implant - Screw endosteal dental implant, two-piece

Access comprehensive regulatory information for Dentis Implant - Screw endosteal dental implant, two-piece in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Eledent Pty Ltd, manufactured by Dentis Co Ltd in South Korea. The device registration started on July 19, 2021.

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
Class IIb
Dentis Implant - Screw endosteal dental implant, two-piece
Australia TGA ARTG Registered Device
Good Name: Eledent Pty Ltd - Dentis Implant - Screw endosteal dental implant, two-piece
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Intended Purpose

The device is indicated for use in partially or fully edentulous mandibles and maxillas in support of single or multiple units restorations and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 19, 2021
Effective Date
July 19, 2021
Sponsor
Manufacturer
Country
South Korea
Address
99 Seongseoseo-ro Dalseo-gu, Daegu