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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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