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510(k) Data Aggregation

    K Number
    K022641
    Device Name
    TOKUYAMA REBASE II
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2002-10-02

    (55 days)

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

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For relining denture surfaces, to repair a fractured denture, or to form a new denture base.
    Device Description
    The product is a chairside denture relining material for relining, repairing and rebasing removable dentures. It is substantially equivalent to the company's Tokuso Rebase (K896981). The product is offered in two versions of differing in curing time; i.e., Fast and Normal. The product complies with ADAS No. 17 and has been approved for marketing by the Japanese Ministry of Health and Welfare.
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    K Number
    K011854
    Device Name
    TOKUYAMA M-BOND
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2001-09-04

    (83 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.
    Device Description
    The product is a self cured adhesive resin cement.
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    K Number
    K011685
    Device Name
    BISTITE II DC
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2001-07-31

    (61 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a dental cement in various applications, including luting, repair of fractured bridge resins, cementation of adhesive bridge prostheses and CR core posts.
    Device Description
    The product is a dental cement which can be either light cured or self cured.
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    K Number
    K010267
    Device Name
    PALFIQUE ESTELITE LV CLEAR
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2001-02-27

    (29 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002863
    Device Name
    PALFIQUE ESTELITE LV
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2001-01-04

    (113 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993917
    Device Name
    TOKUYAMA ONE-UP-BOND F
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    2000-02-02

    (77 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.
    Device Description
    The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.
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    K Number
    K991711
    Device Name
    BISTITE II SC
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1999-07-07

    (49 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a dental cement in various applications, including luting, repair of fractured porcelains or crown and bridge resins, cementaiton of adhesive bridge prostheses and CR core posts.
    Device Description
    The product is a self curing dental cement for use in the cementation of dental devices, luting, repair of fractured porcelains or crown and bridge resins, cementation of adhesive bridges and CR core posts.
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    K Number
    K982537
    Device Name
    TOKUYAMA SOFRELINER
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-08-24

    (34 days)

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

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a denture reliner
    Device Description
    The product is a denture relining resin material for use in relining the tissue contact surface of dentures. It is not intended for over-the-counter (OTC) use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
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    K Number
    K980054
    Device Name
    PALFIQUE ESTELITE
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-04-27

    (111 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in dental procedures as a resin filling material
    Device Description
    The product is a tooth shade resin material for use in dental restorations. It consists of the company's Tokuyama's Mac Bond II bonding agent and Palfique Estelite Paste. Mac Bond II is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices. After curing, restoration is completed with Palfique Estelite Paste or other composite resin brands.
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    K Number
    K980058
    Device Name
    TOKUSO MAC BOND II
    Manufacturer
    TOKUYAMA AMERICA, INC.
    Date Cleared
    1998-04-27

    (111 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKUYAMA AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth
    Device Description
    The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.
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