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510(k) Data Aggregation

    K Number
    K091701
    Device Name
    STRAUMANN MODIFIED DENTAL ABUTMENT
    Manufacturer
    INSTITUT STRAUMANN AG
    Date Cleared
    2009-12-22

    (195 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K062129
    Why did this record match?
    Device Name :

    STRAUMANN MODIFIED DENTAL ABUTMENT

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

    Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

    Modified Dental Implant Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)

    Device Description

    The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The text is a 510(k) summary for a Modified Dental Implant Abutment, primarily focusing on its regulatory classification, intended use, and substantial equivalence to a predicate device. It does not include details on performance testing, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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