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510(k) Data Aggregation

    K Number
    K210039
    Device Name
    CORE1 Implant System
    Manufacturer
    Cybermed Inc.
    Date Cleared
    2022-01-07

    (366 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161244,K190837,K123988,K172100,K161689,K140507,K173570,K173141,K181138,K072642,K153521,K120847,K153639
    Why did this record match?
    Reference Devices :

    K161244, K190837, K123988, K172100, K161689, K140507, K173570, K173141, K181138, K072642, K153521, K120847

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

    CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

    CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

    Device Description

    CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.

    CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.

    CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.

    AI/ML Overview

    The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.

    Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.

    However, I can extract information related to the device's performance through non-clinical testing.

    Here's a breakdown of the relevant information provided:

    1. A table of acceptance criteria and the reported device performance:

    The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.

    Test PerformedAcceptance CriteriaReported Device Performance
    Bacterial Endotoxin TestAccording to USP and ANSI/AAMI ST72:2011. Testing limit of 20 EU/device for blood contacting and implanted device.Confirmed that the endotoxin test reagent (PTS cartridge) and laboratory environment were suitable, meeting endotoxin standards and established criteria. Implies performance within the accepted limit.
    Fatigue TestingAccording to ISO 14801:2016 and FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Objective: Confirm permanent restoration of the implant without failure.Performed on the subject device and reference device K190837 to confirm covering permanent restoration of the implant without failure. The language "to confirm covering permanent restoration of the implant without failure" implies successful completion meeting the standard.
    Surface AnalysisNot explicitly stated as a separate acceptance criterion but is part of material characterization.SEM & EDS analysis showed surface roughness leading to a macroroughness and no other impurity on the surface of the final product. This indicates the desired surface characteristics were achieved.
    Gamma SterilizationAccording to ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013, and ISO 11137-3:2006. Objective: Acceptable range of densities of other product in carrier and confirm process stability.Evaluation showed an acceptable range of densities of other products in the carrier and confirmed process stability. Concluded that the packaging with gamma sterilization of the subject device is equivalent to predicate/reference devices, with a shelf life of 5 years.
    End User SterilizationAccording to ISO 17665-1:2006, ISO 17665-2:2009, and ANSI/AAMI ST79:2010/A4:2013.Performed according to the stated standards. The implicit result is that it meets the requirements for end-user sterilization.
    Biocompatibility TestingAccording to ISO 10993-1:2018 and FDA Guidance Document "Use of International Standard ISO 10993-1...", and ISO 10993-5:2009.Performed for each subject device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices, which includes assurance of biocompatibility.

    2. Sample size used for the test set and the data provenance:

    • Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
    • Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    Not applicable. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    Not applicable, as this is non-clinical bench testing against established standards.

    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 is a dental implant, not an AI/diagnostic device.

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

    Not applicable. This is a dental implant, not an AI/diagnostic device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).

    8. The sample size for the training set:

    Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."

    9. How the ground truth for the training set was established:

    Not applicable, as there is no "training set."

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