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

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.

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TGA ARTG Official Data
Class I
Class I
digit Power system - Two-component dental material applicator, electric
Australia TGA ARTG Registered Device
Good Name: Dentsply Sirona Pty Ltd - digit Power system - Two-component dental material applicator, electric
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Intended Purpose

Dispenser is indicated for intraoral delivery of flowable dental materials

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
Manufacturer
Country
United States of America
Address
38 West Clarke Avenue, Milford, Delaware, 19963