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510(k) Data Aggregation

    K Number
    K143515
    Device Name
    Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Date Cleared
    2015-10-01

    (294 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K083480
    Why did this record match?
    Reference Devices :

    K083480

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

    Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

    Inclusive® Zirconia Abutments are compatible with the following bone-level implants:

    • Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
    • Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
    • Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
    Device Description

    Inclusive Zirconia Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw.

    The purpose of this 510(k) filing is to validate our inclusive abutment screw to be used with our Inclusive® Zirconia Abutments that are compatible with the following bone-level implants:

    • Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
    • Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
    • Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)

    The predicate device utilizes an OEM abutment screw vs. the inclusive abutment screw used by the proposed device.

    AI/ML Overview

    The provided document is a 510(k) Pre-market Notification for Inclusive® Zirconia Abutments. This document describes the device and its claimed substantial equivalence to a predicate device, focusing on non-clinical testing. It does not include information on acceptance criteria for a study proving device performance in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.

    Therefore, I cannot provide the requested information regarding:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set or data provenance.
    • Number of experts used to establish ground truth or their qualifications.
    • Adjudication method.
    • MRMC comparative effectiveness study or related effect size.
    • Standalone performance (algorithm only).
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    This document pertains to a traditional medical device (dental abutments) and its regulatory clearance through a substantial equivalence pathway, primarily supported by bench testing (fatigue and static load failure testing) in accordance with relevant FDA guidance and ISO standards. It does not involve AI/ML components or associated studies for diagnostic or prognostic performance.

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