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510(k) Data Aggregation

    K Number
    K221966
    Device Name
    Dynamic TiBase
    Manufacturer
    Talladium Espana, SL
    Date Cleared
    2022-09-15

    (72 days)

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

    Talladium Espana, SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
    Device Description
    The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, two-piece titanium base abutments that require the fabrication of patient-specific custom zirconia superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.
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    K Number
    K162021
    Device Name
    3.0 Dynamic TiBase
    Manufacturer
    TALLADIUM ESPANA, SL
    Date Cleared
    2018-05-04

    (652 days)

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

    TALLADIUM ESPANA, SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
    Device Description
    Not Found
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