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510(k) Data Aggregation

    K Number
    K042278
    Device Name
    ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
    Manufacturer
    ORAL OSTEODISTRACTION, L.P.
    Date Cleared
    2005-01-28

    (158 days)

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

    ORAL OSTEODISTRACTION, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
    Device Description
    The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.
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    K Number
    K034045
    Device Name
    ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
    Manufacturer
    ORAL OSTEODISTRACTION, L.P.
    Date Cleared
    2004-03-23

    (85 days)

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

    ORAL OSTEODISTRACTION, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.
    Device Description
    The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.
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    K Number
    K014001
    Device Name
    DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3
    Manufacturer
    ORAL OSTEODISTRACTION, L.P.
    Date Cleared
    2003-02-04

    (427 days)

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

    ORAL OSTEODISTRACTION, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.
    Device Description
    Distraction Osteogenesis Rod Appliances are used for mandibular bone distraction. The major components include: - 1. KLS Martin bone plates and screws. - Ormco Stainless steel crowns, Herbst Rods. 2. - 3. Leone expansion screws.
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