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510(k) Data Aggregation

    K Number
    K013230
    Device Name
    CERCON BASE
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2001-10-25

    (28 days)

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

    DEGUSSA - NEY DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.
    Device Description
    Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.
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    K Number
    K011333
    Device Name
    CERCON CERAM
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2001-08-20

    (110 days)

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

    DEGUSSA - NEY DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993514
    Device Name
    DEFINITE
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2000-02-24

    (129 days)

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

    DEGUSSA - NEY DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V.
    Device Description
    Definite® is a light cured composite offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.
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    K Number
    K993897
    Device Name
    CERGOGOLD
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2000-01-10

    (55 days)

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

    DEGUSSA - NEY DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces
    Device Description
    The product in the form of pellets
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