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510(k) Data Aggregation

    K Number
    K983461
    Device Name
    UNI-FLEX RESIN
    Date Cleared
    1999-04-13

    (194 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS-ATLANTIC DENTAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Uni-flex Resin is a flexible material that is used to produce the denture base in prosthetic partials.
    Device Description
    Uni-flex Resin is packed and sealed in aluminum cartridges which are especially made to fit the Injection Mold System machine. To begin the production of a partial a cartridge is heated to 490'F. This allows the material becomes molten. The process of melting lasts ten minutes. After the material becomes molten the operator turns the handle of the Injection Mold System. This forces the material to inject into a previously prepared dental mold encased in an Injection Mold Flask. After the injection the cool down period lasts three minutes, the operator must remove the flask from the machine during this time. Then a twenty minute bench cool down period follows, only after the twenty minutes mold is removed from the flask. After this elapsed time the denture is now ready for finishing and high shine polish.
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