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510(k) Data Aggregation

    K Number
    K021457
    Device Name
    FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
    Manufacturer
    Date Cleared
    2002-08-01

    (87 days)

    Product Code
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    PENTRON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Flex Span Temporary Crown & Bridge Material is intended to be used to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
    Device Description
    Flex Span Temporary Crown & Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the capability of being dual-cured, ic, visible light cure and/or self-cured. The optional light curing ability will give the dentist a choice of not waiting too long for the material to fully cure, if there is a need to fasten the hardening of the material.
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