Dental solid-state laser system

Australia - English - Department of Health (Therapeutic Goods Administration)

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Divinitus Consulting
Class IIb
Authorization status:
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Public Summary

Summary for ARTG Entry:


Dental Axess Pty Ltd - Dental solid-state laser system

ARTG entry for

Medical Device Included Class IIb


Dental Axess Pty Ltd

Postal Address

Suite 6 Level 3 56 Delhi Road,North Ryde, NSW, 2113


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




Biolase Inc

4 Cromwell

Irvine, CA, 92618

United States Of America


1. Dental solid-state laser system

Product Type

Medical device system

Effective date



47880 Dental solid-state laser system

Intended purpose

This is a solid state dental laser that is intended to be used for a wide range of hard and soft tissue

procedures. From decay removal, cavity preparation, root canals, smile design, gum and bone surgical

procedures during dental treatment. This device can excise, vaporize, ablate, and coagulate oral soft

tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses

produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

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Produced at 03.11.2017 at 03:08:38 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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