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510(k) Data Aggregation

    K Number
    K160979
    Device Name
    Inclusive Abutments
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Date Cleared
    2016-11-04

    (211 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Inclusive Abutments

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

    Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.

    All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

    Device Description

    Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Inclusive® Abutments." It confirms the device's substantial equivalence to predicate devices and outlines regulatory requirements.

    However, this document does not contain information about acceptance criteria for device performance or any study data that proves the device meets such criteria. It is a regulatory approval letter, not a clinical or performance study report.

    Therefore, I cannot provide the requested information based on the input given.

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