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510(k) Data Aggregation

    K Number
    K170022
    Device Name
    Klockner Vega TiBase for CEREC
    Manufacturer
    SOADCO S.L.
    Date Cleared
    2017-11-16

    (317 days)

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

    SOADCO S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Klockner Vega TiBase for CEREC® abutments are titanium alloy abutments placed onto Klockner Vega Implants to provide support for customized prosthetic restorations. The Klockner Vega TiBase for CEREC® abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Klockner Vega TiBase for CEREC® abutments are to be designed and milled using Sirona CEREC Premium SW 4.2 software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
    Device Description
    Klockner Vega TiBase for CEREC® abutments are two-piece abutment (composed of the ti-base component and a ceramic mesostructure or coping) fabricated by using the Sirona Dental CAD/CAM System and are to be used with Klockner Vega Dental Implant Systems, with conical and hexagonal internal connection, platforms MV, NV, RV. The Klockner Vega TiBase for CEREC® are Ti-base abutments, made of titanium alloy. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC® systems, and the base portion is available in three models to fit three Klockner® dental implant platforms.
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