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510(k) Data Aggregation

    K Number
    K251206

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-09-24

    (159 days)

    Product Code
    Regulation Number
    872.1800
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Digital X-Ray DentiMax Pro Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photons and convert them into dental images that may be stored, viewed, and manipulated by dentists for the diagnosis of disease of the teeth, jaw, and oral structures.

    Device Description

    The Digital X-Ray DentiMax Pro Imaging System consists of intraoral digital sensors and the optional DentiMax Imaging Software application. This system provides image acquisition, storage, and display functions for dental radiography. The digital intraoral x-ray sensors are based on complementary metal-oxide semiconductor (CMOS) technology. A scintillating material converts the incident x-rays into visible light, the light is coupled optically to a CMOS technology light detection imager and then is converted to digital data. A high-speed direct USB interface enables a simple connection to a computer without need for an additional control box. The design of the sensor assembly supports the automatic detection of incident x-rays to generate digital images for intraoral applications, once armed via a software command. The DentiMax Imaging Software application functions as a viewing software for image acquisition, enhancement, and display; however, it is not required for use of the sensors. The sensors are also compatible with other FDA-cleared dental imaging software commonly available in the marketplace. The optional DentiMax positioner kit helps ensure the system is aligned correctly to capture accurate dental images. The major function of the Digital X-Ray DentiMax Pro Imaging System is to convert X-rays into high-resolution digital images suitable for dental diagnostic use.

    AI/ML Overview

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