Australia TGA ARTG record

Dental implant suprastructure device, permanent

Australia TGA ARTG Registered Device · Ivoclar Vivadent Pty Ltd · Sagemax Bioceramics Inc · Class IIb · Started July 05, 2024

Good Name: Ivoclar Vivadent Pty Ltd - Dental implant suprastructure device, permanent

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 05, 2024
Effective Date: July 05, 2024

Sponsor

Name: Ivoclar Vivadent Pty Ltd

Manufacturer

Name: Sagemax Bioceramics Inc
Country: United States of America
Address: 34210 / 9th Avenue South Suite 118, Federal Way, WA, 98003

Intended purpose

Single-tooth restorations in anterior and posterior teeth, 3-unit bridges up to the second premolar as the terminal abutment, implant-supported hybrid restorations for the replacement of single teeth.

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 IIb is sponsored by Ivoclar Vivadent Pty Ltd, manufactured by Sagemax Bioceramics Inc in United States of America. The device registration started on July 05, 2024.

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.