BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Anthogyr FlexiBase® titanium bases for Axiom® BL

    K Number: K231072 · Decision Jan 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    10
    Review Days
    265

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    Basic Information

    Device Name
    Anthogyr FlexiBase® titanium bases for Axiom® BL
    K Number
    K231072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anthogyr
    Date Received
    April 14, 2023
    Decision Date
    January 4, 2024
    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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