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510(k) Data Aggregation

    K Number
    K133706
    Device Name
    ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
    Date Cleared
    2014-08-21

    (261 days)

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

    **ZL MICRODENT-ATTACHMENT GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
    Device Description
    The NaturaLLock single-stage implant for immediate restoration combines the endosteal and prosthetic implant sections in one piece (integrated abutment). The anatomically shaped implant has a self-tapping thread. The NaturaLLock implant system includes single-stage implants, dental tools, instruments, drills, drill guide sleeves and a surgical tray, which contains a complete set of instruments structured according to the logical sequences of surgery. The system is colour coded as follows: red Ø 3.5 mm, yellow Ø 4.3 mm, blue Ø 5.0 mm, green Ø 6.0 mm. The instruments are laser marked with the following information: drills: Ø and length, implant driver: Ø
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