Dental solid-state laser system

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

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Available from:
Divinitus Consulting
Class:
Class IIb
Authorization status:
Included
Authorization number:
290701

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Public Summary

Summary for ARTG Entry:

290701

Dental Axess Pty Ltd - Dental solid-state laser system

ARTG entry for

Medical Device Included Class IIb

Sponsor

Dental Axess Pty Ltd

Postal Address

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

Australia

ARTG Start Date

27/06/2017

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Biolase Inc

4 Cromwell

Irvine, CA, 92618

United States Of America

Products

1. Dental solid-state laser system

Product Type

Medical device system

Effective date

27/06/2017

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

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.

Visit www.tga.gov.au for contact information

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