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

    Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

    K Number: K254145 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    2
    Review Days
    171

    Basic Information

    Device Name
    Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
    K Number
    K254145
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smart Denture Conversions, LLC
    Date Received
    December 22, 2025
    Decision Date
    June 11, 2026
    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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    Other Clearances by Smart Denture Conversions, LLC

    K Number Device Name
    K242064 Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)