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LED dental light, battery-powered

Access comprehensive regulatory information for LED dental light, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Dental101 Pty Ltd, manufactured by Surgimag Co Ltd in South Korea. The device registration started on August 01, 2023.

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 I
Class I
LED dental light, battery-powered
Australia TGA ARTG Registered Device
Good Name: Dental101 Pty Ltd - LED dental light, battery-powered
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Intended Purpose

A battery-powered, cordless device designed to provide illumination during dental or minor surgical procedures. The light-emitting diode (LED) light features a narrow, high-powered beam and can be surgeon head-mounted or loupe-mounted.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 01, 2023
Effective Date
August 01, 2023
Manufacturer
Country
South Korea
Address
(Palbok-dong-2-ga)-104 34 Sangni 1-gil, Deokjin-gu, Jeonju-si, Jeollabuk-do, 54882