Australia TGA ARTG record

Head-worn light, battery-powered

Australia TGA ARTG Registered Device · Osseo Dental · LumaDent Inc · Class I · Started May 31, 2018

Good Name: Osseo Dental - Head-worn light, battery-powered

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 31, 2018
Effective Date: May 31, 2018

Sponsor

Name: Osseo Dental

Manufacturer

Name: LumaDent Inc
Country: United States of America
Address: 314 W 5th Street, Carson City, NV, 89703

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.

About this record

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 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.