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510(k) Data Aggregation

    K Number
    K103280
    Device Name
    BHDENTAL IMPLANT SYSTEM
    Manufacturer
    BHDENTAL LTD
    Date Cleared
    2011-02-24

    (111 days)

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

    BHDENTAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The BHdental Implant System consists of one and two stage endosseous form dental implant, internal and external hexagonal; internal octagonal; cover screws and healing caps; abutment systems, superstructures and surgical instruments.
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