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510(k) Data Aggregation

    K Number
    K983227
    Device Name
    POWER BLOCK
    Manufacturer
    KREATIV, INC.
    Date Cleared
    1998-12-11

    (87 days)

    Product Code
    EIE,DAT
    Regulation Number
    872.6300
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POWER BLOCK

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

    PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.

    Device Description

    PowerBlock is a white, light reflective, paint on dam.

    AI/ML Overview

    This is a 510(k) clearance letter for the PowerBlock device. It indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.

    Therefore, I cannot provide the information requested in your prompt based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the full 510(k) submission which would include the performance data.

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