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510(k) Data Aggregation
K Number
K033147Device Name
CLEARTOOTH DIGITAL X-RAY SYSTEM
Manufacturer
Date Cleared
2003-12-30
(91 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CLEARTOOTH ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.
Device Description
The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.
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