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Dental diode laser system - ARTG 284004

Access comprehensive regulatory information for Dental diode laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 284004 and sponsored by Ultradent Australia Pty Ltd, manufactured by Azena Medical LLC in United States of America. The device registration started on December 23, 2016.

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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Class IIb
ARTG 284004
Class IIb
Dental diode laser system
ARTG ID: 284004
Good Name: Ultradent Australia Pty Ltd - Dental diode laser system
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Intended Purpose

The intended use of the 810+980nm Diode Laser is to remove, ablate and coagulate tissue, mainly used for dental surgical procedures and is marketed as a dental soft tissue surgical product. The main intended users for this particular device are general dentists, oral surgeons, orthodontists performing procedures where tissue needs to be removed, ablated or coagulated.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
284004
Start Date
December 23, 2016
Effective Date
December 23, 2016
Manufacturer
Country
United States of America
Address
3021 Citrus Circle ,Ste 180, Walnut Creek, California, 94598