DEXIS Product “Indications For Use”
CariVu is a diagnostic aid for the detection of open or incipient carious lesions above the gingiva and for monitoring the progress of such lesions. Indications for use for CariVu are detection of smooth surface caries, detection of occlusal carries, detection of proximal caries, detection of initial caries, detection of secondary caries, and detection of cracks.
Substantiated Product Claim
Proximal dentin lesions represented in CariVu images correlate to the actual condition in the tooth with 99% accuracy.
DEXIS FS Ergo Sensor
The FS Ergo sensor is a digital sensor which is intended to acquire dental intra-oral radiography images. The FS Ergo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs.
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.
DEXshield is a dental X-ray position indicating device and a patient protective shield. It is intended for dental radiographic purposes to align the examination site with the X-ray beam and to protect the patient from unnecessary radiation exposure during radiologic procedures by providing an attenuating barrier to radiation.
Substantiated Product Claim
In a laboratory setting, DEXshield plus the DEXIS Platinum Sensor was determined to reduce absorbed dose by at least 30% as compared to the Universal Ring plus the DEXIS Platinum Sensor.
DEXcam Intra-oral Cameras
The DEXcam intra-oral camera system and accessories are indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
DEXhub is intended to provide the electronic transfer or exchange of medical device data without controlling or altering the functions or parameters of any connected medical devices.
DEXIS Imaging Suite, DEXIS Eleven, and DEXIS Mac Software
The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.
DEXIS CloudVu is a web-based software used for general dental and maxillofacial diagnostic image review that allows users alternate access to image data using a common web-browser. It provides the ability to view, enhance, annotate, compare, and export images by accessing an existing image database available in a distributed environment.
DEXIS go is an optional patient image presentation application for portable devices to be used with the DEXIS Software. It allows presentation of intra-oral and extra-oral images to the patients.
DEXIS photo is an optional patient picture capture application for portable devices to be used with the DEXIS Software. It provides a method to capture patient portraits and extra-oral photos on portable devices and transfer them to the DEXIS Software.