Australia TGA ARTG record

LED dental light, line-powered

Australia TGA ARTG Registered Device · Henry Schein Halas · Planmeca Oy · Class I · Started July 30, 2021

Good Name: Henry Schein Halas - LED dental light, line-powered

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

Name: Henry Schein Halas

Manufacturer

Name: Planmeca Oy
Country: Finland
Address: Asentajankatu 6, Helsinki, 00880

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.

About this record

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.