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510(k) Data Aggregation

    K Number
    K220022
    Device Name
    TRATE Dental Implant System
    Manufacturer
    Date Cleared
    2022-04-04

    (89 days)

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

    Trate AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TRATE Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. TRATE Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
    Device Description
    The TRATE Dental Implant System is an endosseous dental implant and abutment system consisting of screw-type implants manufactured of Titanium Alloy (Ti6AIV4. acc. to EN ISO 5832-3/ASTM F136). The implants are blasted with HAP / TCP for surface roughening, acid-etched and anodized. The cover screws, abutment fixation screws and abutments are made of Titanium Alloy (Ti6A14V). Some subject devices are surfaced anodized. TRATE Dental Implants are two-piece implants: TRATE Dental Implant System implant type is a two-component ROOTFORM implant with combined thread and tapered connection is intended for surgical placement in the upper or lower jaw to support crowns, bridges or overdentures in edentulous and partially edentulous jaws of patients in order to restore the patients chewing for single or multiple unit restorations. TRATE Dental Implant System implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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