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510(k) Data Aggregation
K Number
K172918Device Name
DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
Manufacturer
KaVo Dental Technologies, LLC
Date Cleared
2017-12-18
(84 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
KaVo Dental Technologies, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEXIS / KaVo sensor is a USB-driven digital 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.
Device Description
The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
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