Australia TGA ARTG record

Dentis Implant - Screw endosteal dental implant, two-piece

Australia TGA ARTG Registered Device · Eledent Pty Ltd · Dentis Co Ltd · Class IIb · Started July 19, 2021

Good Name: Eledent Pty Ltd - Dentis Implant - Screw endosteal dental implant, two-piece

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

Name: Eledent Pty Ltd

Manufacturer

Name: Dentis Co Ltd
Country: South Korea
Address: 99 Seongseoseo-ro Dalseo-gu, Daegu

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.

About this record

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.