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510(k) Data Aggregation

    K Number
    K040063
    Device Name
    INSPEKTOR PRO
    Manufacturer
    INSPEKTOR DENTAL CARE BV
    Date Cleared
    2004-06-24

    (163 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K983658
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSPEKTOR DENTAL CARE BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Inspektor™ Pro is intended to be used as an aid in the diagnosis of dental caries.

    The Inspektor™ Pro is indicated as an aid in the diagnosis of dental caries.

    Device Description

    The Inspektor™ Pro consists of a systembox equipped with a handpiece, mounted in a trolley together with a computer, a monitor, mouse, keyboard and footswitch.

    AI/ML Overview

    While the provided document mentions the Inspektor™ Pro device, its intended use, and substantial equivalence to a predicate device, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for that specific information based on the given text.

    The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results in the same way a clinical trial report would.

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