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510(k) Data Aggregation

    K Number
    K972351
    Device Name
    SENDAX MDI (MINI DENTAL IMPLANT)
    Manufacturer
    SENDAX MDIC MANAGEMENT, INC.
    Date Cleared
    1997-11-24

    (153 days)

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

    SENDAX MDIC MANAGEMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a self-tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown & bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. Representative applications include the following: - t Temporary (transitional) supports for fixed or removable implant-supported prostheses while conventional implants are integrating . - * Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes Ox integrating implants. - 本 Introductory system for nervous or apprehensive potential implant patients, offering a simple methodology for testing out the actual "feel" of boneanchored implants, without the major committment to final restorations; or as an interim system for medically compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication & general well-being, at modest cost levels.
    Device Description
    Self-capping citanium threaded screw, 1.8mm in width by 14,17,19,&22mm lengchs
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