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

    VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS

    K Number: K981954 · Decision Jan 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    235

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    Basic Information

    Device Name
    VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
    K Number
    K981954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthline Implants, Inc.
    Date Received
    June 4, 1998
    Decision Date
    January 25, 1999
    Product Code
    NRQ
    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
    NRQ Blade-Form Endosseous Dental Implant

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