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

    BONE DRILL

    K Number: K945706 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    1516
    Applicant Total
    2
    Review Days
    235

    Basic Information

    Device Name
    BONE DRILL
    K Number
    K945706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OSTEO IMPLANT CORP.
    Date Received
    November 21, 1994
    Decision Date
    July 14, 1995
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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