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510(k) Data Aggregation

    K Number
    K082700
    Device Name
    TEMPORARY COLD.V AND SELF-CURE DENTINE
    Manufacturer
    MAJOR PRODOTTI DENTARI S.P.A.
    Date Cleared
    2008-12-09

    (85 days)

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

    MAJOR PRODOTTI DENTARI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    temporary.cold.v and self-cure dentine are temporary cold-curing indirect crowns & bridges materials, Poly-methyImethacrylate based. Powder and liquid. Intended use: - Construction of temporary crowns and bridges - - Immediate crown brush-modeling - For gypsum or silicone key pouring technique - - For rapidly repairing acrylic crowns and bridges -
    Device Description
    Temporary.cold.v and self-cure dentine are chemically activated poly(methylmethacrylate) based, crown and bridge materials for temporary dental prosthesis. They can be used for: - Construction of temporary crowns and bridges . - . Immediate crown brush-modeling - . For gypsum or silicone key pouring technique - . For rapidly repairing acrylic crowns and bridges Temporary.cold.v and self-cure dentine are self-curing acrylic resins composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
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    K Number
    K082153
    Device Name
    MAJOR.REPAIR
    Manufacturer
    MAJOR PRODOTTI DENTARI S.P.A.
    Date Cleared
    2008-11-25

    (118 days)

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

    MAJOR PRODOTTI DENTARI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid. It is used to: - repair and rebase prosthesis - temporary prosthesis -
    Device Description
    Major.repair is a cold-curing polymer for dental prosthesis. For reparing and rebasing dentures. Powder and liquid. It can be used to: - repair and rebase prosthesis . - temporary prosthesis . Major.repair is a self-curing polymer composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.
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    K Number
    K081884
    Device Name
    MAJOR.BASE 20
    Manufacturer
    MAJOR PRODOTTI DENTARI S.P.A.
    Date Cleared
    2008-10-08

    (98 days)

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

    MAJOR PRODOTTI DENTARI S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: - dental prosthesis - partial prosthesis - clasp prosthesis -
    Device Description
    Major.base 20 is a denture base, poly(methyl methacrylate)-based polymers for dental prosthesis. It can be used for: - Total prosthesis . - Partial prosthesis . - Clasp dentures e Major base 20 is a heat cure denture base material composed of a poly-methylmethacrylate polymer powder and a liquid consisting of methylmethacrylate and other ingredients solution.
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