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510(k) Data Aggregation

    K Number
    K070184
    Device Name
    DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT
    Manufacturer
    OSPOL AB
    Date Cleared
    2008-03-24

    (430 days)

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

    OSPOL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ospol AB, Ospol Dental Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
    Device Description
    The Ospol Dental Implant System consists of 4 implants, diameter 4,0 mm, and length from 8,0 to 15,0 mm, 2 standard Abutments (high and low) and 2 Anatomic Abutments (high and low) including healing abutments, cover and abutment screws.
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