BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Straumann Screw Retained Abutments

    K Number: K171757 · Decision Nov 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    166

    Basic Information

    Device Name
    Straumann Screw Retained Abutments
    K Number
    K171757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann USA, LLC (on behalf of Institut Straumann AG)
    Date Received
    June 14, 2017
    Decision Date
    November 27, 2017
    Product Code
    NHA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NHA Abutment, Implant, Dental, Endosseous

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.

    Sherlock

    FDA 510(k)
    FDA Class 2 ·Dental

    MIST IC

    FDA 510(k)
    FDA Class 2 ·Dental

    Geo Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Dynamic TiBase

    FDA 510(k)
    FDA Class 2 ·Dental

    Neodent Implant System - Custom Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Straumann USA, LLC (on behalf of Institut Straumann AG)

    K Number Device Name
    K171769 Straumann PURE Ceramic Implants