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510(k) Data Aggregation

    K Number
    K103089
    Device Name
    SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS
    Manufacturer
    MIS - IMPLANT TECHNOLOGIES LTD.
    Date Cleared
    2011-09-15

    (331 days)

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

    MIS - IMPLANT TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. MIS short implants are to be used only with straight abutments.
    Device Description
    The MIS short implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows: Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm The implants surface is sand blasted and acid etched. The MIS short implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures. The MIS short implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.
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    K Number
    K080458
    Device Name
    MIS CREST WIDENER
    Manufacturer
    MIS - IMPLANT TECHNOLOGIES LTD.
    Date Cleared
    2008-12-17

    (301 days)

    Product Code
    MQN
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIS - IMPLANT TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.
    Device Description
    The MIS crest widener is used to widen a narrow alveolar crest which has sufficient height so as to prepare the ridge for implantation. With this technique. bone augmentation is avoided and the implant is placed in the correct lateral position. The Crest widener is made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The device consists of 4 arms, 2 on each side, connected with guiding pins and an activating screw. The Crest Widener is inserted after cutting 3 mucoperiosteal incisions (without stripping the bone) cutting and splitting the narrow alveolar crest. By rotating the activating screw, each pair of arms moves apart from the other 2 arms, thus pushing the buccal cortical bone apart. The device is supplied with a fine Titanium ligature for attachment to a neighbor tooth during the treatment period. Activating starts 5 - 7 days (latency period) after the insertion of the device. By separating the cortical plates, new bone is created in between (Distraction Osteogenesis). The device is not provided sterile and should be sterilized before use.
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    K Number
    K040807
    Device Name
    MIS DENTAL IMPLANT SYSTEM
    Manufacturer
    MIS - IMPLANT TECHNOLOGIES LTD.
    Date Cleared
    2004-06-09

    (72 days)

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

    MIS - IMPLANT TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIS 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.
    Device Description
    The MIS Dental Implant System consists of one and two stage implants, internal and external hexagonal; cover screw and healing caps; abutment systems and suprastructures; surgical instruments.
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