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

    BRANEMARK SYSTEM ABUTMENTS COMPLETE

    K Number: K925769 · Decision Apr 14, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    64
    Review Days
    149

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    Basic Information

    Device Name
    BRANEMARK SYSTEM ABUTMENTS COMPLETE
    K Number
    K925769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nobelpharma USA, Inc.
    Date Received
    November 16, 1992
    Decision Date
    April 14, 1993
    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

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