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510(k) Data Aggregation

    K Number
    K052700
    Device Name
    PANA-SPRAY
    Manufacturer
    NSK AMERICA CORP.
    Date Cleared
    2005-12-20

    (83 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K052700
    Predicate For
    K113674,K131014
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

    Device Description

    This new device is a lubricant and is intended for use to lubricate the dental and medical surgical handpieces.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental handpiece lubricant called "Pana-Spray", indicating it is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but not specific performance criteria or a study proving those criteria are met.

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