About the Evidence Document
The “Evidence Document” provides a comparison of the imaging technologies using the DEXIS Platinum Sensor with DEXIS Imaging Software (“DEXIS”) and the Schick 33 Sensor with Patterson Imaging Software (“Schick 33”) in internally conducted laboratory bench studies*. The performance bench data was generated by using the listed devices within the boundaries of the cleared indications for use. The data was obtained using standard methodologies (phantoms, controlled conditions, etc.) that are accepted in the industry as representative of real world experience that is obtained in larger, heterogeneous and more complex populations, with a broader range of end-users. These types of studies and the presented data are useful for identifying less evident but common technological benefits and limitations. The presented data can be recreated using the presented technologies under the same conditions for repeatability purposes.
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DEXIS Sensor Competitive Performance Study, December 2013, by Brad Carlson, Ph.D., and Scott Kravis, Ph.D.
DEXIS Sensor Clinical Evaluation Report, December 2013, by Christine Hart, CDA, and Lisa Ratnow
Indications For Use
DEXIS Platinum Sensor
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient. Date published: May 28, 2009. For DEXshield Indications for Use, visit www.dexis.com/ifu.
Schick 33 Sensor
The Schick 33 system is intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed, enhanced, printed, and saved. Source: Schick 33 System User Guide, April 2, 2013, B1051079 Rev. B, Copyright 2013 by Sirona Dental, Inc.
The dental professionals quoted in this document evaluated DEXIS Digital X-ray and provided their views and opinions. They have no financial interest in DEXIS, LLC.
DEXIS, DEXIS Platinum, ClearVu, PerfectSize, WiseAngle, PureImage, TrueComfort, DEXshield and DEXIS go are trademarks of DEXIS, LLC.
Schick is a trademark of Sirona Dental GmbH.
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