Summary for ARTG Entry:
Carestream Health Australia Pty Ltd - CAD/CAM unit, dental, chairside
ARTG entry for
Medical Device Included Class 1
Carestream Health Australia Pty Ltd
Level 3 / 176 Wellington Parade,East Melbourne, VIC, 3002
ARTG Start Date
Medical Device Class 1
- 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.
Carestream Health Inc
150 Verona Street
Rochester, New York, 14608
United States Of America
1. CAD/CAM unit, dental, chairside
Single Device Product
38597 CAD/CAM unit, dental, chairside
An intraoral scanner used to take a digital 2D and 3D impression of the patient's mouth/teeth. For
computer-aided design (CAD) and manufacturing/production (CAM) of dental restorations.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:41:45 AEDT
This is not an ARTG Certificate document.
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