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    K Number
    K040946
    Device Name
    ANKYLOS DENTAL IMPLANT SYSTEM
    Manufacturer
    FRIADENT GMBH
    Date Cleared
    2004-07-01

    (80 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K012681
    Predicate For
    K040757
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healling or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on 4 interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

    Device Description

    The ANKYLOS dental implant system has been previously cleared for commercial distribution. The purpose of this application is to present additional instructions for use sheets for the product. The system and methodology of implantation has not changed with the new labeling.

    AI/ML Overview

    This 510(k) submission (K040946) for the ANKYLOS® Dental Implant System does not contain a study to prove the device meets acceptance criteria related to performance metrics, a multi-reader multi-case (MRMC) comparative effectiveness study, or a standalone AI algorithm performance study. This submission is primarily focused on presenting additional instructions for use sheets for a device that has already been cleared (predicate 510(k) K012681).

    Therefore, many of the requested elements for describing a study are not applicable to this particular submission. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through a new study.

    Here's an breakdown based on the provided text, indicating what is present and what is not:

    Acceptance Criteria and Device Performance

    Acceptance Criteria (for 510(k) Clearance)Reported Device Performance (as claimed for Substantial Equivalence)
    Substantially equivalent in designThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of design.
    Substantially equivalent in materialsThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of materials.
    Substantially equivalent in coatingsThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of coatings.
    Substantially equivalent in mechanical strengthThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of mechanical strength.
    Substantially equivalent in prosthetic optionsThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of prosthetic options.
    Substantially equivalent in indications for useThe ANKYLOS® Dental Implant System is substantially equivalent to the current ANKYLOS® Dental Implant Systems in terms of indications for use. The specific indications are for surgical placement in upper or lower jaw arches, to provide a root form for single or multiple unit prosthetic appliance attachment to restore chewing function. Implants can use 2-stage or single-stage (immediate loading) processes, with immediate loading restricted to the anterior mandible (4 interforaminal placed implants, not single, unsplinted).
    No change in system and methodology of implantationThe system and methodology of implantation has not changed with the new labeling.
    No change in technological characteristicsThe technological characteristics of the ANKYLOS® Dental Implant System have not changed with the addition of the new labeling.

    Summary of the "Study" (or basis for clearance):

    This submission is a "Special 510(k)" or a similar type where the changes are minimal and do not impact safety or effectiveness. The "study" here is a comparison to a predicate device (Dentsply Ceramco ANKYLOS® Dental Implant System, K012681) to demonstrate substantial equivalence, particularly because the primary purpose of this specific application is to present "additional instructions for use sheets." The manufacturer asserts that design, materials, coatings, mechanical strength, prosthetic options, indications for use, system and methodology of implantation, and technological characteristics have not changed.

    Non-Applicable or Not Provided Information from the Text:

    Due to the nature of this 510(k) (updates to labeling for an already cleared device), the following information, which would typically be present for a clinical or performance study, is not provided in the given text:

    1. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
    3. Adjudication method for the test set: Not applicable. No test set needing adjudication is described.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-based device, and no MRMC study is mentioned.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-based device, and no standalone algorithm performance is mentioned.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There's no performance evaluation generating new data that would require a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the existing predicate device.
    7. The sample size for the training set: Not applicable. This is not an AI-based device, and no training set is mentioned.
    8. How the ground truth for the training set was established: Not applicable. No training set is mentioned.
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