Pure Global

Dental anaesthesia injection kit, non-medicated

Access comprehensive regulatory information for Dental anaesthesia injection kit, non-medicated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Minimax Implant Pty Ltd, manufactured by Genoss Co Ltd in South Korea. The device registration started on October 24, 2016.

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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TGA ARTG Official Data
Class IIa
Class IIa
Dental anaesthesia injection kit, non-medicated
Australia TGA ARTG Registered Device
Good Name: Minimax Implant Pty Ltd - Dental anaesthesia injection kit, non-medicated
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Intended Purpose

An electric-operated device with rechargeable battery used to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the pain during restorative or surgical dental procedure. This device does not contain the phamaceuticals which are typically held within a cartridge produced to fit the syringe.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 24, 2016
Effective Date
October 24, 2016
Manufacturer
Country
South Korea
Address
Gyeonggi R&DB Center 1F 906-5 Lui-dong Yeontong-gu Suwon-si, Gyeonggi-do, 443-766