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

    BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE

    K Number: K103291 · Decision Nov 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    32
    Review Days
    361

    Basic Information

    Device Name
    BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
    K Number
    K103291
    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
    November 8, 2010
    Decision Date
    November 4, 2011
    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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