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510(k) Data Aggregation

    K Number
    K213576
    Device Name
    Tatum Surgical Dental Implant System
    Date Cleared
    2022-07-15

    (247 days)

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

    Suncoast Dental, Inc. dba Tatum Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing. The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.
    Device Description
    The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.
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