Australia TGA ARTG record

Dental diode laser system

Australia TGA ARTG Registered Device · Gritter Dental Australia Pty Ltd · Biolase Inc · Class IIb · Started December 12, 2019

Good Name: Gritter Dental Australia Pty Ltd - Dental diode laser system

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

Sponsor

Name: Gritter Dental Australia Pty Ltd

Manufacturer

Name: Biolase Inc
Country: United States of America
Address: 4 Cromwell, Irvine, CA, 92618

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.

About this record

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.