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510(k) Data Aggregation

    K Number
    K131014
    Device Name
    PANA SPRAY PLUS
    Manufacturer
    NSK AMERICA CORP.
    Date Cleared
    2013-08-12

    (123 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    NSK AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.
    Device Description
    PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant. The lubricant is introduced into the handpiece through the air-drive pipe or the back end. PANA SPRAY Plus can be used for the maintenance of high speed handpieces, low speed handpieces, and air motors and should be used after each patient and prior to sterilization of handpiece and air motors.
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    NSK AMERICA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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