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Torque wrench, manual, dental - ARTG 429350

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 registered under ARTG number 429350 and 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.

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TGA ARTG Official Data
Class I
ARTG 429350
Class I
Torque wrench, manual, dental
ARTG ID: 429350
Good Name: Biomet 3i Australia Pty Ltd - Torque wrench, manual, dental
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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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
429350
Start Date
November 30, 2023
Effective Date
November 30, 2023
Manufacturer
Country
Italy
Address
Via Nazionale Nord 21/A, Colico LC, 23823