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510(k) Data Aggregation

    K Number
    K052271
    Device Name
    RINSENDO
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2006-05-26

    (280 days)

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

    RINSENDO

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

    The RinsEndo is used for root canal irrigation/ disinfection.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "RinsEndo". This document confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use (root canal irrigation/disinfection) and allows it to be marketed.

    However, the document does NOT contain any information regarding:

    • Acceptance criteria for the device's performance.
    • The specifics of any study performed to prove the device meets acceptance criteria.
    • Device performance results.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness study details or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for training was established.

    This 510(k) letter is an administrative document about market clearance, not a technical report detailing the performance evaluation studies. Therefore, I cannot extract the requested information from the provided text.

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