Pure Global

Dental implant suprastructure device, temporary

Access comprehensive regulatory information for Dental implant suprastructure device, temporary in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Partmaker, manufactured by Partmaker in Australia. The device registration started on October 05, 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.

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Class I
Class I
Dental implant suprastructure device, temporary
Australia TGA ARTG Registered Device
Good Name: Partmaker - Dental implant suprastructure device, temporary
Pure Global
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Intended Purpose

A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a re-useable device.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
Start Date
October 05, 2021
Effective Date
October 05, 2021
Sponsor
Manufacturer
Country
Australia
Address
1/11 Korong Road, Heidelberg West, VIC, 3081