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510(k) Data Aggregation

    K Number
    K111321

    Validate with FDA (Live)

    Device Name
    REMOTE VIEW SOFTWARE
    Manufacturer
    CARIESCAN LTD.
    Date Cleared
    2011-05-17

    (6 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Type
    Special
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K090598
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

    Device Description

    Not Found

    AI/ML Overview

    This document only contains marketing and regulatory information and does not contain the information required to answer the request. The document is a 510(k) premarket notification approval letter for the CarieScan PRO device. It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements. It doesn't include details about acceptance criteria or specific study results beyond the general "indications for use."

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