Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K063769
    Device Name
    ALPHA BIO BONE FIXATION SCREW SYSTEM
    Manufacturer
    ALPHA-BIO TEC LTD
    Date Cleared
    2007-03-30

    (100 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA-BIO TEC LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alpha-Bio Bone Fixation Screw System® is used to stabilize and fixate bone grafts, bone filling materials, and / or barrier membranes used for regeneration of bone in the oral cavity. The system includes titanium screws 1.2mmd and 1.6mmd diameter, and drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure.
    Device Description
    The Alpha-Bio Bone Fixation Screw System consists of titanium alloy Gr-5 screws with 1.2mmd and 1.6mmd diameter, and with 4mm-12mm lengths. This system includes drill instrument for fixating the screw to the bone in the oral cavity at regeneration procedure
    Ask a Question
    K Number
    K063770
    Device Name
    ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
    Manufacturer
    ALPHA-BIO TEC LTD
    Date Cleared
    2007-03-26

    (96 days)

    Product Code
    OAT, DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA-BIO TEC LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
    Ask a Question
    K Number
    K063364
    Device Name
    ALPHA BIO DENTAL IMPLANT SYSTEM
    Manufacturer
    ALPHA-BIO TEC LTD
    Date Cleared
    2007-03-14

    (127 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA-BIO TEC LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alpha-Bio Dental 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's chewing function. The Alpha-Bio Dental Implant System® is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The Alpha-Bio Dental Implant System® consists of one and two stage endosseous form dental implants, internal and external hexagonal; internal octagonal hexagonal; one piece implants system; cover screws and healing caps; abutment systems and superstructures; surgical instruments.
    Ask a Question

    Page 1 of 1