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510(k) Data Aggregation

    K Number
    K990983
    Device Name
    MODIFICATION TO IMTEC SENDAX MDI
    Manufacturer
    IMTEC CORP.
    Date Cleared
    1999-04-13

    (20 days)

    Product Code
    DZE
    Regulation Number
    872.3640
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    Matched: '872.3890'

    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 application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention. Representative applications include the following: - * Temporary (transitional supports for fixed or removable implant-supported prosthesies while conventional implants are integrating. - * Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to avoid iatrogenic damage to healing grafts, membranes or integrating implants. - * Introductory system for nervous or apprehensive potential patients, offering a simple methodology for testing out the actual "feel of bone anchored implants, without the major commitment to final restorations; or as an interim system for medical compromised, handicapped or terminally ill patients to enhance their comfort by maintaining a reasonable level of speech, mastication and general well-being, at modest cost levels.
    Device Description
    Self-tapping titanium screw, 1.8 mm in width by 13, 15and 18 mm lengths.
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    K Number
    K961704
    Device Name
    MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    1996-07-26

    (85 days)

    Product Code
    ELS
    Regulation Number
    872.3890
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    Matched: '872.3890'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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