Sirona Dental Systems GmbH
Supplement to the Operating Instructions
64 55 328 D3492
D3492.201.08.01.23 08.2013
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Further use of Sirona Dental CAD/CAM
System
Further use of Sirona Dental CAD/CAM System
The Sirona Dental CAD/CAM System is also an optical impression
system for computer assisted design and manufacturing (CAD/CAM)
according to 21 CFR 872.3661.The system records the topographical
characteristics of teeth, dental impressions, or stone models for use in the
computer-assisted design and manufacturing of dental restorative
prosthetic devices. Such devices are exempt from the premarket
notification procedures.
3 Further use of Sirona Dental CAD/CAM System
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