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510(k) Data Aggregation
K Number
K163282Device Name
Apex Dental Sensors
Manufacturer
Date Cleared
2017-02-28
(99 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Masterlink LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Apex Dental Sensors is intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Device Description
The Apex Dental Sensors is an electronic medical device used to acquire intra-oral radiographic images. The sensor can be operated by Radiologists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the assistance of the patient. The Apex Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The Apex Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The Apex Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.
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