Pure Global

Dental solution, reaming aid - ARTG 482387

Access comprehensive regulatory information for Dental solution, reaming aid in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 482387 and sponsored by Gunz Dental, manufactured by Premier Dental Products Company in United States of America. The device registration started on March 13, 2025.

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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Class IIa
ARTG 482387
Class IIa
Dental solution, reaming aid
ARTG ID: 482387
Good Name: Gunz Dental - Dental solution, reaming aid
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Intended Purpose

This is a dental material that is a Root Canal Preparation Cream that is intended to be used remove calcifications and lubricate the root canal to permit more efficient instrumentation. This material lubricates the canal so the instruments can cut freely without binding.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482387
Start Date
March 13, 2025
Effective Date
March 13, 2025
Sponsor
Manufacturer
Country
United States of America
Address
1710 Romano Drive, Plymouth Meeting, Pennsylvania, 19462