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510(k) Data Aggregation

    K Number
    K070905
    Device Name
    ENDOSSEOUS DENTAL IMPLANT SYSTEM
    Manufacturer
    SOUTHERN IMPLANTS, INC.
    Date Cleared
    2007-05-24

    (52 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K003620,K020617,K033171,K052490,K053478,K061169,K964220,K023113,K061319
    Predicate For
    K072917,K163060,K163634
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prosteses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    Device Description

    The NSI Implant System is intended to the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for an endosseous dental implant system, and it primarily focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices. It does not contain details about performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

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