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Dental diode laser system

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 sponsored by Gritter Dental Australia Pty Ltd, manufactured by Biolase Inc in United States of America. The device registration started on December 12, 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 IIb
Class IIb
Dental diode laser system
Australia TGA ARTG Registered Device
Good Name: Gritter Dental Australia Pty Ltd - Dental diode laser system
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Intended Purpose

This is a Diode Laser is a portable surgical and therapeutic device designed for a wide variety of dental soft tissue applications including incision, excision, ablation, vaporization and coagulation of oral soft tissue, dental whitening, as well as for use in providing temporary relief of minor pain.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 12, 2019
Effective Date
December 12, 2019
Manufacturer
Country
United States of America
Address
4 Cromwell, Irvine, CA, 92618