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510(k) Data Aggregation

    K Number
    K972198
    Device Name
    DENT-TEMP ACRYLIC
    Manufacturer
    HEALTH-DENT INTL., INC.
    Date Cleared
    1997-12-17

    (189 days)

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

    HEALTH-DENT INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer. DENT-TEMP™ ACRYLIC System is recommended for use in Restorative Dentistry. Whenever making of temporary crown and bridge restoration is required, this most durable, fast setting and easy to trim and polish, polymer system can be used.
    Device Description
    DENT-TEMP™ ACRYLIC is a self-curing system. It is available in three Vita-Shades. A-1, A-2, A-3.5. made out of Methacrylate Polymer Powder and DENT-TEMPTM LIQUID used with powders, made out of Memhylmethacrylate Monomer.
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