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510(k) Data Aggregation

    K Number
    K012174
    Device Name
    ERIS LAYERING MATERIALS
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-08-27

    (46 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Eris Layering materials are porcelain powders used in our pressable ceramic system, Eris Layering materials are personal free single unit, and multiple unit bonded crown and bridge restorations.
    Device Description
    Eris Layering materials are porcelain powders used in our pressable ceramic system
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    K Number
    K011491
    Device Name
    HELIOSEAL CLEAR CHROMA
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-08-16

    (93 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K011492
    Device Name
    IN TEN-S
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-07-05

    (51 days)

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

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011490
    Device Name
    MODIFICATION TO EXCITE
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-06-27

    (43 days)

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

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011022
    Device Name
    BIOUNIVERSAL PDF
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-05-02

    (28 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011023
    Device Name
    D.SIGN 96
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-05-02

    (28 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010381
    Device Name
    D.SIGN 30
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-03-06

    (26 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010250
    Device Name
    TETRIC CERAM HB
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-02-28

    (33 days)

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

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003293
    Device Name
    EXCITE DSC
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-02-06

    (109 days)

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

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003407
    Device Name
    SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-01-26

    (86 days)

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

    IVOCLAR NORTH AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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