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510(k) Data Aggregation

    K Number
    K083543
    Device Name
    DENOVISMED DENTAL IMPLANT SYSTEMS
    Date Cleared
    2009-03-06

    (98 days)

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

    DENOVIS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For immediate or delayed placement and function on single-tooth and/or multiple tooth applications in the maxillary and or mandibular arches to support crowns, bridges, and overdentures in edentulous or partially edentulous patients. Immediate loading is indicated for single tooth and/or multiple tooth applications when there is good primary stability and an appropriate occlusal load.
    Device Description
    The DenovisMed Dental Implant System is intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The System consists of the DenovisMed Dental Implant, a self-tapping, threaded, root-formed dental implant as well as straight abutments and related prosthetic components.
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