93904b9c-659d-438a-be19-49f920db0f4dUpdatePublished52022-01-312016-09-24In Commercial DistributionEKAV100730420PrimaryHIBCCDEXIS Platinum™ intraoral sensor1.007.3042PLU5101I019717844DEXIS LLC1Digital intraoral sensorfalsefalsefalsetruefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+18888833947support@dexis.comK09045800044905Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.falseActiveMUHSystem,x-ray,extraoral source,digitalHandling Environment Temperaturefalsefalse