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    K Number
    K062418
    Device Name
    K-SPRAY, MODEL 085-2715
    Manufacturer
    SCICAN
    Date Cleared
    2006-10-19

    (62 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-SPRAY, MODEL 085-2715

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

    K-SPRAY is intended for the maintenance and lubrication of dental handpieces.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece maintenance and lubrication device called "K-SPRAY." This document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details about an AI/algorithm-based medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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