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510(k) Data Aggregation

    K Number
    K203808
    Device Name
    Multi-unit Abutment, Multi-unit Angled Abutment
    Manufacturer
    MegaGen Implant Co. Ltd.
    Date Cleared
    2021-10-20

    (296 days)

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

    MegaGen Implant Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
    Device Description
    The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.
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