2 results
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62ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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cone-beam CT system
FDA Enforcement
Class II
·Ongoing·KaVo Dental Technologies LLC·May 1, 2019
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo 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.
FDA Enforcement
Class II
·Terminated·KaVo Dental Technologies LLC·May 29, 2019