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510(k) Data Aggregation

    K Number
    K242217
    Device Name
    Surcam Dental Implant System
    Date Cleared
    2025-01-29

    (184 days)

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

    Surcam Medical Devices and Developments Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surcam 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments. Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.
    Device Description
    The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.
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