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510(k) Data Aggregation

    K Number
    K221972
    Device Name
    Warantec Custom Abutment
    Manufacturer
    Warantec Co., Ltd,
    Date Cleared
    2023-10-02

    (454 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K161713,K192457,K172345,K110308
    Why did this record match?
    Device Name :

    Warantec Custom Abutment

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

    The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.

    All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.

    Device Description

    Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.

    The document is a 510(k) summary for a dental abutment, primarily focusing on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. It lists non-clinical testing data such as:

    • Steam sterilization validation
    • Biocompatibility of the material
    • Fatigue testing according to ISO 14801:2016 and FDA Special Controls Guidance Document.
    • Non-clinical worst-case MRI review.

    However, it does not provide specific acceptance criteria values for these tests or reported device performance against those criteria in a tabular format. It also explicitly states: "No clinical data were included in this submission."

    Therefore, I cannot extract details like:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for a test set or data provenance.
    • Number of experts or their qualifications.
    • Adjudication method.
    • Multi-reader multi-case (MRMC) comparative effectiveness study results.
    • Standalone performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.
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