LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152787
    Device Name
    ST Internal Fixture System
    Manufacturer
    T-PLUS IMPLANT TECH. CO., LTD.
    Date Cleared
    2016-07-22

    (301 days)

    Product Code
    DZE,NHA,SUB
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K052369,K132992
    Why did this record match?
    Device Name :

    ST Internal Fixture System

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

    The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

    The ST Internal Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    Device Description

    The ST Internal Fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options.

    The devices covered by this submission are ST internal fixture, screw and abutment. The diameters of ST internal fixtures are 3.5 mm, 4.0 mm, 4.5 mm, and 5.0 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm.

    AI/ML Overview

    The applicant, T-Plus Implant Tech. Co., Ltd., is seeking 510(k) clearance for their ST Internal Fixture System. The device is a dental implant system intended for placement in the upper or lower jaw to support prosthetic devices and restore chewing function, for both two-stage and single-stage surgical procedures. It is also intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

    The submission aims to demonstrate substantial equivalence to two predicate devices: the Ti Star Implant System (K132992), also from T-Plus Implant Tech. Co., Ltd., and the ExFeel Dental Implant System (K052369) from MegaGen Co., Ltd.

    Here's an analysis of the provided information regarding acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (Implied)Reported Device Performance
    SterilizationDevice must be sterile.Leveraged from predicate device (K132992).
    Shelf LifeDevice must maintain integrity and function over its shelf life.Leveraged from predicate device (K052369).
    BiocompatibilityDevice must be biocompatible (non-toxic, non-sensitizing, etc.).Leveraged from predicate device (K052369). (Cytotoxicity, Intracutaneous Reactivity, Maximization Sensitization, Systemic Injection, Pyrogen, 90-Day Bone Implantation Study)
    Fatigue TestingDevice must withstand fatigue according to ISO 14801.Test results comply with ISO 14801.
    RBM Surface Coating ValidationSurface must be free of particles/chemicals from RBM process.Cleaning validation test and SEM/EDX analysis conducted; results verify removal of particles/chemicals.

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

    The document provides details on non-clinical testing. For the performance tests conducted, such as "Fatigue test" and "RBM surface coating," specific sample sizes are not explicitly stated in the provided text. The data provenance is derived from these non-clinical tests performed on the "proposed device." There is no indication of clinical data, so discussions of country of origin or retrospective/prospective studies are not applicable to the testing mentioned.

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

    This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment for ground truth.

    4. Adjudication Method for the Test Set:

    This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No additional clinical testing was necessary for a determination of substantial equivalence."

    6. Standalone (Algorithm Only) Performance:

    This information is not applicable as the device is a physical medical implant, not an algorithm or software. The "performance testing" described refers to the physical properties of the implant.

    7. Type of Ground Truth Used:

    For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 14801) and scientific methods (e.g., cleaning validation, SEM/EDX analysis). For biocompatibility and sterilization, it is implied that the predicate devices had established ground truth based on their respective testing protocols and regulatory approvals.

    8. Sample Size for the Training Set:

    This information is not applicable as the document describes a medical device seeking substantial equivalence based on non-clinical testing, not a machine learning model that requires a training set.

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

    This information is not applicable as there is no training set for the described device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1