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EzSensor T, Intra-oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

EzSensor T is a solid state x-ray imager designed for dental radiographic applications. EzSensor T provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.

The Computed Oral Radiology System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134. The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.

The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.

The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation. All the systems include a scintillator coupled to a digital image sensor, electronic circuits to analyze the digital image and transmit the digital image to a personal computer for viewing and further management of the file.

The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.

The EnVision Intraoral Dental X-Ray Machine (Wall Mounted and Mobile) is intended to be used for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system. The EnVision Intraoral Dental X-Ray Machine is a highly efficient user-friendly Constant-potential radiation system that produces, clear, sharp radiography with minimal elapsed exposure time. Includes 2 versions- integrated and remote, that are compatible to open to open to and the (30 cm round, and equipped with rectangular SSD's available as optional).

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film. The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module. The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.