Indications for Use

CLINIVIEW™ Dental Imaging Software

CLINIVIEW 11: CLINIVIEW software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

DEXcam™ Intraoral Cameras/h3>

The DEXcam intraoral 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

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™ CariVu™

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™ CloudVu

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

DEXIS go is an optional patient image presentation application for portable devices to be used with the DEXIS Software. It allows presentation of intraoral and extraoral images to the patients.

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 intraoral and extraoral dental cameras.

DEXIS™ photo

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.

DEXIS™ Platinum Sensor

The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The DEXIS sensor shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral 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

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.

DIGORA™ Optime

The DIGORA Optime imaging system is indicated for capturing, digitization and processing of intraoral X-ray images stored in imaging plate recording media.

ESTETICA™ Treatment Units

The ESTETICA Dental Treatment Unit and accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and accessories are designed for use by a trained professional in the field of general dentistry.

FOCUS™ X-ray

FOCUS is intended to be used for producing diagnostic X-ray radiographs of dentition, jaws and other oral structures.

FS Ergo Sensor

The FS Ergo sensor is a digital sensor which is intended to acquire dental intraoral 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.

GXDP-300™

The GXDP-300 dental panoramic X-ray equipment is intended for dental radiographic examinations by producing digital radiographs of teeth, temporomandibular joints and other oral structures by dentists and other legally qualified professionals.

GXDP-700™ Series

The GXDP-700 dental panoramic, cephalometric and cone beam computed tomography X-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

GXS-700™

The GXS-700 is a USB-driven digital sensor, which is intended to acquire dental intraoral radiography images. The GXS-700 shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The GXS-700 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.

i-CAT FLX — Cone Beam 3D and 2D Panoramic Dental Imaging System

Devices of the i-CAT family consist of an X-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.

Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.

CAUTION: U.S. Federal Law (USA) restricts the sale of this device to or on the order of a dentist or other licensed practitioner.

Invivo Dental Imaging Software by Anatomage

InVivoDental is intended for use as a front-end software interface for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. It is also intended for use as a planning and simulation software in the placement of dental implants and surgical treatment.

NOMAD Pro 2™ X-ray System

The NOMAD Pro 2 X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

NOMAD Pro 2™ X-ray System (Available in the U.S. only)

The NOMAD Pro 2 X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

ORTHOPANTOMOGRAPH™ OP 2D

The ORTHOPANTOMOGRAPH OP 2D dental panoramic X-ray equipment is intended for dental radiographic examinations by producing digital radiographs of teeth, TM-joints and other oral structures by dentists and other legally qualified professionals.

ORTHOPANTOMOGRAPH™ OP 3D

ORTHOPANTOMOGRAPH OP 3D is an X-ray device to take panoramic and 3D images of the craniomaxillofacial complex for use in diagnostic support. ORTHOPANTOMOGRAPH OP 3D must only be used and operated by dentist and other qualified professionals.

ORTHOPANTOMOGRAPH™ OP 3D Pro

The ORTHOPANTOMOGRAPH OP 3D Pro dental panoramic, cephalometric and cone beam computed tomography X-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

ORTHOPANTOMOGRAPH™ OP200 D

ORTHOPANTOMOGRAPH OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph™ OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related hereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.

Tx STUDIO™

Tx STUDIO is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologists, clinicians, referring physicians, and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute images, utilizing standard PC hardware. Additionally, Tx STUDIO is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning, and surgical treatments.

This device is not indicated for mammography use.

VixWin™ Platinum

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.