Australia TGA ARTG record

AR Submerged Implant System - Screw endosteal dental implant, two-piece

Australia TGA ARTG Registered Device · GLEN DENTAL PTY LTD · Biotem Co Ltd · Class IIb · Started June 06, 2023

Good Name: GLEN DENTAL PTY LTD - AR Submerged Implant System - Screw endosteal dental implant, two-piece

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: June 06, 2023
Effective Date: June 06, 2023

Sponsor

Name: GLEN DENTAL PTY LTD

Manufacturer

Name: Biotem Co Ltd
Country: South Korea
Address: 422 Sasang-ro Sasang-gu, Busan-si

Intended purpose

an implant substructure which is inserted into the human body to support prosthetic appliances like artificial teeth to be used to restore masticatory function of the patient

About this record

Access comprehensive regulatory information for AR Submerged Implant System - 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 GLEN DENTAL PTY LTD, manufactured by Biotem Co Ltd in South Korea. The device registration started on June 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.