Australia TGA ARTG record

Dental material, desensitizing resin

Australia TGA ARTG Registered Device · Smileflex · Zhengzhou Huaer Electro-Optics Technology Co Ltd · Class I · Started January 20, 2022

Good Name: Smileflex - Dental material, desensitizing resin

Device classification

Risk Class: Class I
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: January 20, 2022
Effective Date: January 20, 2022

Sponsor

Name: Smileflex

Manufacturer

Name: Zhengzhou Huaer Electro-Optics Technology Co Ltd
Country: China
Address: 11th Floor Block B Building 18 Henan International University Science Park, (East District), Zhengzhou, Henan, 450001

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.

About this record

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 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.