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Dental solid-state laser system

Access comprehensive regulatory information for Dental solid-state 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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Class IIb
Class IIb
Dental solid-state laser system
Australia TGA ARTG Registered Device
Good Name: Gritter Dental Australia Pty Ltd - Dental solid-state laser system
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Intended Purpose

These lasers are all-tissue dental devices which utilize an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr:YSGG) solid-state laser energy and water atomization technology to cut, shave, contour, roughen, etch and reset oral hard tissues and direct laser energy to perform oral soft tissue incision, excision, ablation and coagulation.

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