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510(k) Data Aggregation

    K Number
    K012882
    Device Name
    BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
    Manufacturer
    THERMOELASTIC TECHNOLOGIES, INC.
    Date Cleared
    2001-11-14

    (78 days)

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

    THERMOELASTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for Use as a long-term resilient lining material for removable dentures, and to reline, repair, clasp or rebase dentures.
    Device Description
    Not Found
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    K Number
    K994357
    Device Name
    BITEM LOCK, MODELS SW006, SW012
    Manufacturer
    THERMOELASTIC TECHNOLOGIES, INC.
    Date Cleared
    2000-03-14

    (78 days)

    Product Code
    EJF
    Regulation Number
    872.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMOELASTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for Use as an aligning bracket for removable dentures, and to aid in securing dentures.
    Device Description
    The BITEM LOCK product is a thermo-adjustable alignment bracket with the same use as the predicate device. The only difference is the predicate device is Made from metal and this device is a thermo-adjustable material. The base materials for the BITEM LOCK include a methacrylate liquid, a phthalate plasticizer, an EGDMA cross linker and polymer powder. They are ready made for clinical application.
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