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    K Number
    K083205
    Device Name
    NOBELACTIVE 8.5 MM & 18.0 MM
    Manufacturer
    NOBEL BIOCARE AB
    Date Cleared
    2009-02-13

    (106 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K071370
    Why did this record match?
    Device Name :

    NOBELACTIVE 8.5 MM & 18.0 MM

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

    Nobel Biocare's NobelActive implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

    Device Description

    NobelActive 8.5 mm & 18.0 mm implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.

    NobelActive Internal Connection Implants are similar to predicate NobelActive Internal Connection Implants. The NobelActive 8.5 mm and 18.0 mm implants differ from the predicate device in length.

    AI/ML Overview

    This document describes the NobelActive 8.5 mm & 18.0 mm dental implants and their substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

    The provided text is a 510(k) summary for a dental implant, which is a physical medical device. It focuses on device description, indications for use, and a demonstration of substantial equivalence to an existing predicate device based on differences in length for the new models.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these details are not present in the provided documentation for this type of medical device submission.

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