Australia TGA ARTG record

Smartlite Pro Endoactivator - Solution agitator

Australia TGA ARTG Registered Device · Dentsply Sirona Pty Ltd · Dentsply LLC Professional Div t/a Dentsply Professional Dentsply Pharm DENTSPLY RINN Sultan Healthcare Dentsply Sirona Dentsply Sirona Preventative · Class IIa · Started July 15, 2022

Good Name: Dentsply Sirona Pty Ltd - Smartlite Pro Endoactivator - Solution agitator

Device classification

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

Registration information

Start Date: July 15, 2022
Effective Date: July 15, 2022

Sponsor

Name: Dentsply Sirona Pty Ltd

Manufacturer

Name: Dentsply LLC Professional Div t/a Dentsply Professional Dentsply Pharm DENTSPLY RINN Sultan Healthcare Dentsply Sirona Dentsply Sirona Preventative
Country: United States of America
Address: 1301 Smile Way, York, Pennsylvania, 17404

Intended purpose

This device is intended for dental intracanal activation (vibrates to shake-up / “activate” fluid) of irrigating fluids used for cleaning and disinfecting root canals. The device vibrates and shakes up irrigation fluid during a root canal procedure.

About this record

Access comprehensive regulatory information for Smartlite Pro Endoactivator - Solution agitator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Dentsply Sirona Pty Ltd, manufactured by Dentsply LLC Professional Div t/a Dentsply Professional Dentsply Pharm DENTSPLY RINN Sultan Healthcare Dentsply Sirona Dentsply Sirona Preventative in United States of America. The device registration started on July 15, 2022.

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.