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510(k) Data Aggregation

    K Number
    K954758
    Device Name
    ROOTFORM DENTAL IMPLANT SYSTEM
    Date Cleared
    1997-08-18

    (672 days)

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

    SWISS DENTAL CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rootform Dental Implant is an endosseous dental implant intended to provide support for prosthetic attachments. The Rootform Dental Implant is surgically placed in the bone of the upper or lower jaw arches to provide attachment and support for an abetment and prosthetic devices including artificial teeth, bridges, and dentures.
    Device Description
    The Rootform Dental Implant System has two "families" -- one without a hex top with 3.3 mm and 3.8 mm diameter cylinders and a second with a hex lock top with 3.3 mm and 4.0 mm diameters. The components of each system are as follows: Rootform 3.3 mm and 3.8 mm Non-Hex Top Implant System - Implants with internal thread - Cover screws - Healing abutments - Prepable abutments - Bar or tissue abutments - Abutment screws - Tissue abutment with cap - Prosthetic attachment screws Rootform 3.3 mm and 4.0 mm Universal Hex Top Implant System - Implants with internal thread - Cover screws - Fixation screws - Healing abutments - Straight abutments - Angled abutments
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