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Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system - ARTG 318907

Access comprehensive regulatory information for Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 318907 and sponsored by Ultradent Australia Pty Ltd, manufactured by Azena Medical LLC in United States of America. The device registration started on June 14, 2019.

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 318907
Class I
Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system
ARTG ID: 318907
Good Name: Ultradent Australia Pty Ltd - Gemini Photo Biomodulation (PBM) Adaptor Kit - Dental diode laser system
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Intended Purpose

The intended use of the PBM Adapter is to allow the Gemini Laser to provide near-infrared laser energy to a tissue surface for the purpose of photobiomodulation

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
318907
Start Date
June 14, 2019
Effective Date
June 14, 2019
Manufacturer
Country
United States of America
Address
3021 Citrus Circle ,Ste 180, Walnut Creek, California, 94598