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510(k) Data Aggregation

    K Number
    K190837
    Device Name
    Internal Hex Implant System
    Manufacturer
    EBI Inc.
    Date Cleared
    2020-01-22

    (296 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K073116,K170031,K142426
    Why did this record match?
    Reference Devices :

    K073116, K170031, K142426

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Internal Hex Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. For implant bodies Ø4.1 and greater, the Internal Hex Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant bodies with a diameter less than Ø4.1 are intended for immediate loading when using a minimum of 4 implants with lengths >8mm.

    Device Description

    The subject endosseous dental implant bodies are composed of Pure Titanium Grade 4. Internal Hex Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Hex Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Hex Implant System has an internal connection. The surface of the implant bodies has been treated with SLA (Sandblast, Large grit Acid etched). The system consists of BLT II OS Implant Fixtures and various abutments such as Cover Screw, Healing abutment, BestDuo Abutment, BestSolid Abutment, BestOcta Abutment, BestAngled Abutment, Temporary Abutment, Octa Plastic Cylinder, Denture Abutment, Multi-Unit Abutment, Multi-unit Abutment Screw, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, Multi-Unit Cylinder Screw and Abutment Screw.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the EBI Inc. Internal Hex Implant System, as extracted from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The documents describe the successful completion of various tests according to international and national standards. The acceptance criteria are implicitly that the device meets the respective standards and demonstrates substantial equivalence to predicate devices. The reported device performance is that it met these criteria.

    Test TypeStandard / ReferenceAcceptance Criteria (Implicit)Reported Device Performance
    Fatigue TestISO 14801:2016, FDA Guidance (Class II Special Controls)Device is strong enough for intended use under worst-case scenarioMet criteria; demonstrated substantial equivalence
    Cytotoxicity TestISO 10993-5Non-cytotoxicMet criteria; demonstrated biocompatibility and substantial equivalence
    End User Sterilization ValidationISO 17665-1:2006, -2:2009, ANSI/AAMI ST79Effective sterilization for end-user preparationMet criteria
    Biocompatibility TestISO 10993-1BiocompatibleMet criteria; demonstrated biocompatibility
    Accelerated Aging Test (Shelf Life)ASTM F1980-07Maintains performance over shelf lifeMet criteria
    Bacterial Endotoxin TestUSPMeets pyrogenicity limitsMet criteria

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state numerical sample sizes for the test sets. However, it indicates these were non-clinical tests.

    • Provenance: All tests mentioned are non-clinical (laboratory/bench testing). The document does not specify country of origin for the data, but the manufacturer is based in the Republic of Korea. The data is retrospective in the sense that the tests were performed and results analyzed for this submission.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. These are non-clinical engineering and biocompatibility tests against established standards. Ground truth is determined by the specific criteria outlined in the standards, not by expert consensus on interpretations of images or clinical outcomes.

    4. Adjudication Method for the Test Set

    Not applicable, as ground truth is based on objective measurements and compliance with standard specifications rather than expert interpretation.

    5. 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 device is a dental implant system, not an AI-powered diagnostic tool. The submission focuses on the physical and biological properties of the implant and abutments.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    Not applicable. This device is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    The ground truth for the non-clinical tests is based on:

    • Engineering specifications and performance limits defined in international standards (e.g., ISO 14801:2016 for fatigue).
    • Biocompatibility criteria established in ISO 10993 series and USP for pyrogenicity.
    • Sterilization efficacy criteria in ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79, and ISO 11137-1.2.3.
    • Shelf life criteria in ASTM F1980-07.

    8. The Sample Size for the Training Set

    Not applicable. This device is a physical medical device, not a machine learning model that requires a training set. The term "training set" is typically used in the context of AI/ML development.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable for the same reason as point 8.

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