Further Use Of Sirona Dental Cad/Cam System - Sirona CEREC MC Operating Instructions Manual

3 General description
3.3 Further use of Sirona Dental CAD/CAM system
12
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
3.3

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.
● an endosseous dental implant accessory according to 21 CFR
872.3980. The system is used to produce a part that the user can
manually incorporate together with other 3rd party components into a
dental surgery guide, a temporary accessory used with endosseous
dental implants with tissue contact for less than 1 hour (exempt).
Such devices are exempt from the premarket notification procedures.
Dentsply Sirona
63 98 650 D 3439
D 3439.201.07.10.23 10.2017