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Dental Delivery System - Dental delivery system instrument unit, pneumatic - ARTG 461226

Access comprehensive regulatory information for Dental Delivery System - Dental delivery system instrument unit, pneumatic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 461226 and sponsored by Advanced Dental Repairs Pty Ltd, manufactured by DCI International LLC Dba DCI and DCI Edge in United States of America. The device registration started on August 29, 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.

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TGA ARTG Official Data
Class IIa
ARTG 461226
Class IIa
Dental Delivery System - Dental delivery system instrument unit, pneumatic
ARTG ID: 461226
Good Name: Advanced Dental Repairs Pty Ltd - Dental Delivery System - Dental delivery system instrument unit, pneumatic
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Intended Purpose

A powered device providing instruments/equipment to deliver dental treatments to a patient. The dental unit includes a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), with an optional control panel, and can be portable or mounted.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
461226
Start Date
August 29, 2024
Effective Date
August 29, 2024
Manufacturer
Country
United States of America
Address
705 South Springbrook Road Building C, Newberg, Oregon, 97132