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LED dental light, line-powered

Access comprehensive regulatory information for LED dental light, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Henry Schein Halas, manufactured by Planmeca Oy in Finland. The device registration started on July 30, 2021.

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, line-powered
Australia TGA ARTG Registered Device
Good Name: Henry Schein Halas - LED dental light, line-powered
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Intended Purpose

This reusable device projects an intense focused beam of light directly into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 30, 2021
Effective Date
July 30, 2021
Sponsor
Manufacturer
Country
Finland
Address
Asentajankatu 6, Helsinki, 00880