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Dental material, desensitizing resin - ARTG 382850

Access comprehensive regulatory information for Dental material, desensitizing resin in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 382850 and sponsored by Smileflex, manufactured by Zhengzhou Huaer Electro-Optics Technology Co Ltd in China. The device registration started on January 20, 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.

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Class I
ARTG 382850
Class I
Dental material, desensitizing resin
ARTG ID: 382850
Good Name: Smileflex - Dental material, desensitizing resin
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Intended Purpose

The desentising gel is for the treatment of dentinal hypersensitivity. The gel is applied into a custom oral tray and placed on the surface of the teeth for a period of 30 -60 minutes as tooth sensitivity requires in adults over the age of 18 years old. The product consists of potassium nitrate and sodium fluoride in the form of a gel.

Device Classification
Risk Class
Class I
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
382850
Start Date
January 20, 2022
Effective Date
January 20, 2022
Sponsor
Manufacturer
Country
China
Address
11th Floor Block B Building 18 Henan International University Science Park, (East District), Zhengzhou, Henan, 450001