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510(k) Data Aggregation

    K Number
    K984380
    Device Name
    DISPO ETCH
    Manufacturer
    KIS PRODUCTS
    Date Cleared
    2001-08-06

    (972 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIS PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993124
    Device Name
    DISPODRILL
    Manufacturer
    KIS PRODUCTS
    Date Cleared
    2001-08-06

    (686 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIS PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures. Indications for use are identical to PrepStar™ by Danville Engineering Inc. For Use by Dentists Only.
    Device Description
    Disposable Dental Air Abrasion Handpiece
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    K Number
    K993182
    Device Name
    DISPOPROPHY
    Manufacturer
    KIS PRODUCTS
    Date Cleared
    2001-08-06

    (683 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    KIS PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intra-orally to surface clean and remove stain from teeth and dental restorations. For Use by Dentists and Hygienists only.
    Device Description
    Disposable Dental Air Polishing Handpiece
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