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

    HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION

    K Number: K851367 · Decision May 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    8
    Review Days
    46

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    Basic Information

    Device Name
    HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION
    K Number
    K851367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Orthomatrix, Inc.
    Date Received
    April 5, 1985
    Decision Date
    May 21, 1985
    Product Code
    DZE
    Advisory Committee
    Dental
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form

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