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Mandrel, dental - ARTG 361533

Access comprehensive regulatory information for Mandrel, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 361533 and sponsored by KCI Medical Australia Pty Ltd, manufactured by 3M ESPE Dental Products in United States of America. The device registration started on April 12, 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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TGA ARTG Official Data
Class I
ARTG 361533
Class I
Mandrel, dental
ARTG ID: 361533
Good Name: KCI Medical Australia Pty Ltd - Mandrel, dental
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Intended Purpose

Used to hold a rotating dental device, e.g., a disc or strip used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed to provide contouring, finishing, and polishing to dental restorations.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
361533
Start Date
April 12, 2021
Effective Date
April 12, 2021
Manufacturer
Country
United States of America
Address
2510 Conway Avenue, St Paul, Minnesota, 55144-1000