Australia TGA ARTG record

Utility supply system handpiece, irrigation, dental

Australia TGA ARTG Registered Device · Ampac Dental · Dental Components LLC dba DCI International · Class IIa · Started September 01, 2016

Good Name: Ampac Dental - Utility supply system handpiece, irrigation, dental

Device classification

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

Registration information

Start Date: September 01, 2016
Effective Date: September 01, 2016

Sponsor

Name: Ampac Dental

Manufacturer

Name: Dental Components LLC dba DCI International
Country: United States of America
Address: 305 North Springbrook Road, Newberg, OR, 97132

Intended purpose

This is a device that is used to regulate and direct use of water and air to the oral cavity during a dental procedure. The purpose is to irrigate and clean the debris from the field of operation during a dental restorative procedure. This device is commonly referred to a syringe or a triplex syringe.

About this record

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 sponsored by Ampac Dental, manufactured by Dental Components LLC dba DCI International in United States of America. The device registration started on September 01, 2016.

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.