Indications For Use; Further Use Of Sirona Dental Cad/Cam System - Sirona Cerec 3 Operating Instructions Manual

Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit CEREC 3
Intended use of the AU
63 22 700 D 3344
D 3344.201.01.25.23 01.2011
3.2

Indications for use

The Sirona Dental CAD/CAM System is intended for use in partially
or fully edentulous mandibles and maxillae in support of single or
multiple-unit cement retained restorations. The system consists of
three major parts: TiBase, InCoris mesostructure, and CAD/CAM
software. Specifically, the InCoris mesostructure and TiBase
components make up a two-piece abutment which is used in
conjunction with endosseous dental implants to restore the function
and aesthetics in the oral cavity. The InCoris mesostructure may also
be used in conjunction with the Camlog Titanium base CAD/CAM
(types K2244.xxxx) (K083496) in the Camlog Implant System. The
CAD/CAM software is intended to design and fabricate the InCoris
mesostructure. The InCoris mesostructure and TiBase two-piece
abutment is compatible with the following implants systems:
●
Nobel Biocare Replace (K020646)
●
Nobel Biocare Branemark (K022562)
●
Friadent Xive (K013867)
●
Biomet 3i Osseotite (K980549)
●
Astra Tech Osseospeed (K091239)
●
Zimmer Tapered Screw-Vent (K061410)
●
Straumann SynOcta (K061176)
For the USA only
CAUTION: Federal Law (USA) restricts 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. Such devices are exempt from the premarket
notification procedures.
3 General description
Indications for use
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