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510(k) Data Aggregation

    K Number
    K063768
    Device Name
    TITANIUM SCALLOPED ABUTMENT
    Manufacturer
    VIDENT
    Date Cleared
    2007-06-27

    (189 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 31™ external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,
    Device Description
    Titanium Scalloped Abutment
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    K Number
    K060441
    Device Name
    VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
    Manufacturer
    VIDENT
    Date Cleared
    2006-04-27

    (65 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
    Device Description
    Not Found
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    K Number
    K052710
    Device Name
    VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
    Manufacturer
    VIDENT
    Date Cleared
    2006-01-13

    (106 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown. For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
    Device Description
    Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
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    K Number
    K052130
    Device Name
    VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
    Manufacturer
    VIDENT
    Date Cleared
    2005-08-15

    (10 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems. For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
    Device Description
    Vita In-Ceram® 2000 AL Cubes for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
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    K Number
    K050362
    Device Name
    VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
    Manufacturer
    VIDENT
    Date Cleared
    2005-03-15

    (29 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vita PM7 pressable ceramic is to be used for the fabrication of - Single and multi-surface inlays O - Onlays o - Veneers O - Partial crowns ্ - Anterior crowns 0 - Premolar crowns o Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain. For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
    Device Description
    Not Found
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    K Number
    K022996
    Device Name
    VITA IN-CERAM YZ CUBES FOR CEREC
    Manufacturer
    VIDENT
    Date Cleared
    2002-10-09

    (30 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.
    Device Description
    Not Found
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    K Number
    K012473
    Device Name
    VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
    Manufacturer
    VIDENT
    Date Cleared
    2002-09-11

    (405 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis. The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.
    Device Description
    Not Found
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    K Number
    K000597
    Device Name
    VITA RESPONSE
    Manufacturer
    VIDENT
    Date Cleared
    2000-05-17

    (85 days)

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

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990367
    Device Name
    PDQ AND PDQ-TI ABUTMENT
    Manufacturer
    VIDENT
    Date Cleared
    1999-04-21

    (75 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PDQ and PDQ-Ti abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
    Device Description
    PDQ and PDQ-Ti Abutments
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    K Number
    K984198
    Device Name
    WIDE BODY ABUTMENTS
    Manufacturer
    VIDENT
    Date Cleared
    1999-02-18

    (86 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wide Body abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments which do not osseointegrate are to be seated directly on tope of the implant body. The abutments form the substructure of the restored prosthesis.
    Device Description
    Wide Body Abutments
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