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

    BIO-ESTHETIC INDIRECT ABUTMENT

    K Number: K970073 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    46
    Review Days
    176

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    Basic Information

    Device Name
    BIO-ESTHETIC INDIRECT ABUTMENT
    K Number
    K970073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Steri-Oss, Inc.
    Date Received
    January 8, 1997
    Decision Date
    July 3, 1997
    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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