Australia TGA ARTG record

Dental implant suprastructure device, permanent

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

Good Name: GLEN DENTAL PTY LTD - Dental implant suprastructure device, permanent

Device classification

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

Registration information

Start Date: April 06, 2023
Effective Date: April 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

The superstructure of an implant inserted to support a prosthesis, such as an artificial tooth, used to restore the patient's chewing function

About this record

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 IIa is sponsored by GLEN DENTAL PTY LTD, manufactured by Biotem 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.