Australia TGA ARTG record

digit Power system - Two-component dental material applicator, electric

Australia TGA ARTG Registered Device · Dentsply Sirona Pty Ltd · Dentsply LLC also dba Dentsply Caulk · Class I · Started October 03, 2019

Good Name: Dentsply Sirona Pty Ltd - digit Power system - Two-component dental material applicator, electric

Device classification

Risk Class: Class I
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: October 03, 2019
Effective Date: October 03, 2019

Sponsor

Name: Dentsply Sirona Pty Ltd

Manufacturer

Name: Dentsply LLC also dba Dentsply Caulk
Country: United States of America
Address: 38 West Clarke Avenue, Milford, Delaware, 19963

Intended purpose

Dispenser is indicated for intraoral delivery of flowable dental materials

About this record

Access comprehensive regulatory information for digit Power system - Two-component dental material applicator, electric in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dentsply Sirona Pty Ltd, manufactured by Dentsply LLC also dba Dentsply Caulk in United States of America. The device registration started on October 03, 2019.

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.