BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Neoss Ti Reinforced Membrane

    K Number: K143327 · Decision Apr 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    30
    Applicant Total
    9
    Review Days
    144

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    Basic Information

    Device Name
    Neoss Ti Reinforced Membrane
    K Number
    K143327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoss, Ltd.
    Date Received
    November 20, 2014
    Decision Date
    April 13, 2015
    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 Neoss, Ltd.

    K Number Device Name
    K211396 Neoss Individual Prosthetics
    K150669 Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
    K113376 NEOSS PROACTIVE TAPERED IMPLANT
    K090452 NEOSS IMPLANT SYSTEM 03.25
    K081851 NEOSS ACCESS ABUTMENTS
    K083561 NEOSS PROACTIVE IMPLANT
    K071838 NEOSS VARIOUS TITANIUM ABUTMENTS
    K043195 NEO IMPLANT SYSTEM