Intended Use; Further Use Of Sirona Dental Cad/Cam System - Sirona Cerec AC Operating Instructions Manual

3 General description

3.2 Intended use

10
Intended use
3.2
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. For the SSO 3.5 L and SBL 3.3 L
titanium bases, the indication is restricted to the replacement of single
lateral incisors in the maxilla and lateral and central incisors in the
mandible. 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 implant 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)
● Straumann Bone Level (K053088, K062129, K060958)
● Biomet 3i Certain (K014235, K061629)
● Nobel Biocare Active (K071370)
CAUTION
Small diameter implants and large angled abutments in the anterior
region of the mouth due to possible failure of the implant system.
CAUTION
Federal Law (USA) restricts the sale of this device to or on the order
of a physician, dentist, or licensed practitioner.

Further use of Sirona Dental CAD/CAM System

3.3
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.
Sirona Dental Systems GmbH
Operating Instructions CEREC AC