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Utility supply system handpiece, irrigation, dental - ARTG 462077

Access comprehensive regulatory information for Utility supply system handpiece, irrigation, dental in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462077 and sponsored by Ampac Dental, manufactured by DCI International LLC Dba DCI and DCI Edge in United States of America. The device registration started on September 09, 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 462077
Class IIa
Utility supply system handpiece, irrigation, dental
ARTG ID: 462077
Good Name: Ampac Dental - Utility supply system handpiece, irrigation, dental
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Intended Purpose

This is a device that is used transiently in the mouth that is intended to be used to direct the flow of water and or air into the oral cavity of a patient during dental procedures in the mouth.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462077
Start Date
September 09, 2024
Effective Date
September 09, 2024
Sponsor
Manufacturer
Country
United States of America
Address
705 South Springbrook Road Building C, Newberg, Oregon, 97132