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510(k) Data Aggregation

    K Number
    K012681
    Device Name
    ANKYLOS
    Manufacturer
    DENTSPLY CERAMCO
    Date Cleared
    2003-08-22

    (738 days)

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

    DENTSPLY CERAMCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforaminal placed implants, and not indicated for single, unsplinted implants. Patient must be subject for dental treatment with endosseous implants
    Device Description
    Ankylos dental implants consist of uncoated pure titanium (grade 2 per ISO 5832/II). The threaded area features a rough structure, the cervical margin is polished. The implants come packaged in a sterile double glass container for contact-free handling. The cover screw has already been mounted in the implant and is only removed prior to placing the abutment.
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