Intended Use; Further Use Of Sirona Dental Cad/Cam System - Sirona inEos Blue Operating Instructions Manual

Sirona Dental Systems GmbH
Operating Instructions Sirona Dental CAD/CAM System
63 33 632 D3446
D3446.201.02.03.23 07.2011
3.2

Intended use

Indications for use Intended 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)
Note for use in the USA
Note for use in the USA
CAUTION: According to US Federal Law, this product may be sold only
to or by instruction of physicians, dentists, or licensed professionals.
3.3

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.
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