Australia TGA ARTG recordDental implant suprastructure device, permanent
Australia TGA ARTG Registered Device · Novel Dentistree Pty Ltd · Biotem Co Ltd · Class IIa · Started June 26, 2017
Good Name: Novel Dentistree Pty Ltd - Dental implant suprastructure device, permanent
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- June 26, 2017
- Effective Date
- June 26, 2017
- Name
- Biotem Co Ltd
- Country
- North Korea
- Address
- 422 Sasang-ro Sasang-gu, Busan
This is a prefabricated device that is incorporated into, or creates, the necessary suprastructure mimicking preparations of natural teeth. It is used during dental implant restorative procedures and will provide the permanent intermediate fixture level between the dental implant and the final restoration (e.g., bridge, single tooth, overdenture). This device is referred to as an implant abutment.
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 Novel Dentistree Pty Ltd, manufactured by Biotem Co Ltd in North Korea. The device registration started on June 26, 2017.
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.