Operating Instructions

Table Of Contents
3 General description
3.3 Further use of Sirona Dental CAD/CAM system
Dentsply Sirona
Operating Instructions CEREC Primemill
12
67 19 756 D3439
D3439.201.01.01.0209.2019
WARNING
Small diameter implants and angled abutments are not recommended
for the posterior region.
CAUTION
Federal Law (USA) restricts the sale of this device to or on the order
of a physician, dentist, or licensed practitioner.
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.