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

    BioHorizons CAD/CAM Bars

    K Number: K180998 · Decision Sep 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    40
    Review Days
    165

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    Basic Information

    Device Name
    BioHorizons CAD/CAM Bars
    K Number
    K180998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BioHorizons Implant Systems, Inc.
    Date Received
    April 16, 2018
    Decision Date
    September 28, 2018
    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 BioHorizons Implant Systems, Inc.

    K Number Device Name
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    K182070 BioHorizons Tapered IM Implants
    K172576 BioHorizons Tapered Short Implants
    K151621 BioHorizons CAD/CAM Abutments
    K143022 BioHorizons Tapered Internal Implants
    K121787 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
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