Pure Global

Gingival retraction solution - ARTG 482325

Access comprehensive regulatory information for Gingival retraction solution in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 482325 and sponsored by Gunz Dental, manufactured by Premier Dental Products Company in United States of America. The device registration started on March 12, 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 482325
Class IIa
Gingival retraction solution
ARTG ID: 482325
Good Name: Gunz Dental - Gingival retraction solution
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Intended Purpose

This is a dental material that is intended to be used gingival retraction and hemostasis. It is use in restorative and operative dentistry, optionally with gingival retraction cord, prior to taking an impression, cementation, cavity preparation or whenever hemostasis and retraction is required during dental procedures in the mouth.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482325
Start Date
March 12, 2025
Effective Date
March 12, 2025
Sponsor
Manufacturer
Country
United States of America
Address
1710 Romano Drive, Plymouth Meeting, Pennsylvania, 19462