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

    TSV BellaTek Express and BellaTek Flex Abutments

    K Number: K192522 · Decision Dec 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    TSV BellaTek Express and BellaTek Flex Abutments
    K Number
    K192522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet 3i, LLC
    Date Received
    September 13, 2019
    Decision Date
    December 9, 2019
    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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