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Head-worn light, battery-powered - ARTG 303745

Access comprehensive regulatory information for Head-worn light, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 303745 and sponsored by Osseo Dental, manufactured by LumaDent Inc in United States of America. The device registration started on May 31, 2018.

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
ARTG 303745
Class I
Head-worn light, battery-powered
ARTG ID: 303745
Good Name: Osseo Dental - Head-worn light, battery-powered
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Intended Purpose

This LED light is to be attached to PENTAX Surgical loupe system and may be retrofitted to other loupe designs by use of an adapter plate. The LED light is for the purpose of additional light over the surgical field.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
303745
Start Date
May 31, 2018
Effective Date
May 31, 2018
Sponsor
Manufacturer
Country
United States of America
Address
314 W 5th Street, Carson City, NV, 89703