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510(k) Data Aggregation

    K Number
    K060376
    Device Name
    SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24
    Manufacturer
    SIMPLER IMPLANT, INC.
    Date Cleared
    2006-04-25

    (70 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Simpler HA Coated Threaded Dental Implants are endosseous threaded implants used as an artificial root structure to replace missing teeth. They are used to support crowns. bridges, or dentures in the maxilla or mandible area of the mouth.

    Device Description

    Simpler Threaded HA Coated, Models ST 5002-5016, Simpler T

    AI/ML Overview

    I'm sorry, but without further context, I cannot fulfill your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a dental implant device. It primarily discusses regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details you've requested regarding a study proving the device meets acceptance criteria.

    To answer your questions, I would need access to the actual study report or a more detailed summary of the performance testing conducted for the Simpler Threaded HA Coated dental implants.

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