Summary for ARTG Entry:
3M Australia Pty Ltd - CAD/CAM unit, dental, chairside
ARTG entry for
Medical Device Included Class Im
3M Australia Pty Ltd
Locked Bag 19,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class Im
- 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.
3M Espe Dental Products
2510 Conway Avenue
St Paul, Minnesota, 55144-1000
United States Of America
1. CAD/CAM unit, dental, chairside
Medical device system
38597 CAD/CAM unit, dental, chairside
3M True Definition Scanner is an optical impression system used to record the topographical
characteristics of the dentition and preparation areas (including features such as implant scan locator
fixtures, braces, brackets, etc.). In addition it can record the
topographical characteristics of the oral anatomy (such as soft tissue, gingiva and palate). The three
dimensional (3D) model generated from the scan may be further used for the design and manufacturing of
dental restorations including implant supported prostheses, and partial frameworks, and can be used to
design and manufacture physical models of the teeth. It may also be used in conjunction with production of
orthodontic appliances, retainers and accessories.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:17:17 AEDT
This is not an ARTG Certificate document.
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