Australia - English - Department of Health (Therapeutic Goods Administration)
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
Suite 6 Level 3 56 Delhi Road,North Ryde, NSW, 2113
ARTG Start Date
Medical Device Class IIb
- 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.
Irvine, CA, 92618
United States Of America
1. Dental solid-state laser system
Medical device system
47880 Dental solid-state laser system
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 03:08:38 AEDT
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