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

    STRAUMANN MEMBRAGEL

    K Number: K101956 · Decision Dec 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    STRAUMANN MEMBRAGEL
    K Number
    K101956
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann USA (On Behalf of Institut Straumann Ag)
    Date Received
    July 12, 2010
    Decision Date
    December 16, 2010
    Product Code
    NPK
    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
    NPK Barrier, Synthetic, Intraoral

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    Other Clearances by Straumann USA (On Behalf of Institut Straumann Ag)

    K Number Device Name
    K071919 P.004 ABUTMENTS