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510(k) Data Aggregation

    K Number
    K113608
    Device Name
    DEFLEX
    Manufacturer
    NUXEN S.R.L.
    Date Cleared
    2012-04-10

    (126 days)

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

    NUXEN S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.
    Device Description
    Deflex is a pigmented granulated polyamide resin that belongs to the group of amorphous polyamides or co polyamides, which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). The polyamide granules are pigmented so as to achieve aesthetic effects on the manufactured denture.
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    K Number
    K113788
    Device Name
    DEFLEX ACRILATO
    Manufacturer
    NUXEN S.R.L.
    Date Cleared
    2012-03-16

    (85 days)

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

    NUXEN S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is indicated for the manufacturing of bases of partial or full removable dentures, r nis products thatoated for the marketing and pneumatic injection of the material, following the Indications of Use that come with the product.
    Device Description
    Deflex Acrilato is a pigmented polimethyl-methacrilate (PMMA) resin that belongs to the group of thermoplastic polymers which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). the PMMA granules are pigmented so as to achieve aesthetic effects on the manufactured denture.
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