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510(k) Data Aggregation

    K Number
    K153645
    Device Name
    VITA ENAMIC Implant Solutions (IS)
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH CO.
    Date Cleared
    2016-06-30

    (192 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies: (See Table 1 in document for list of compatible Ti Base/Implant Systems).
    Device Description
    VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer. The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows: Ti Base: Sirona TiBase (K111421), CAD/CAM System: Sirona software – inlab 15.0 and above, Sirona software – CEREC 4.4 and above, Titanium Bases: Compatible titanium bases are shown in Table 1. VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form. The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.
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    K Number
    K152373
    Device Name
    VITA VM LC Flow
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2015-12-30

    (131 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure - Individualization of and layering on VITA ENAMIC® - Layering-over long-term temporaries made from VITA CAD-Temp® - Individualization of acrylic teeth - Reproduction of gingival components - Metal-free crowns and three-unit anterior bridges as long-term temporary restorations - Veneering of removable and partially removable dentures (according to the manufacturer's information) - Inlays - Veneers
    Device Description
    VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.
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    K Number
    K132070
    Device Name
    VITA SUPRINITY(R)
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2014-01-31

    (212 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K122269
    Device Name
    ENAMIC
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2012-12-13

    (136 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
    Device Description
    The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
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    K Number
    K102128
    Device Name
    VITABLOCS
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2010-08-11

    (13 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.
    Device Description
    Not Found
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    K Number
    K093446
    Device Name
    VITA VMK MASTER
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
    Date Cleared
    2009-12-03

    (28 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.
    Device Description
    Not Found
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    K Number
    K090644
    Device Name
    VITABLOCS, MODEL VX55-****
    Manufacturer
    VITA ZAHNFABRIK H. RAUTER GMBH & CO.
    Date Cleared
    2009-03-31

    (21 days)

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

    **VITA ZAHNFABRIK H. RAUTER GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.
    Device Description
    Not Found
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