Australia TGA ARTG record

Torque wrench, manual, dental

Australia TGA ARTG Registered Device · Biomet 3i Australia Pty Ltd · Biomec Srl · Class I · Started November 30, 2023

Good Name: Biomet 3i Australia Pty Ltd - Torque wrench, manual, dental

Device classification

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

Registration information

Start Date: November 30, 2023
Effective Date: November 30, 2023

Sponsor

Name: Biomet 3i Australia Pty Ltd

Manufacturer

Name: Biomec Srl
Country: Italy
Address: Via Nazionale Nord 21/A, Colico LC, 23823

Intended purpose

A hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

About this record

Access comprehensive regulatory information for Torque wrench, manual, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Biomet 3i Australia Pty Ltd, manufactured by Biomec Srl in Italy. The device registration started on November 30, 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.