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

    Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)

    K Number: K150669 · Decision Oct 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    9
    Review Days
    206

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    Basic Information

    Device Name
    Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
    K Number
    K150669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoss, Ltd.
    Date Received
    March 16, 2015
    Decision Date
    October 8, 2015
    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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