BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    3.25MM SIMPLER THREADED DENTAL IMPLANT

    K Number: K974856 · Decision Feb 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    3.25MM SIMPLER THREADED DENTAL IMPLANT
    K Number
    K974856
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vancouver Implant Resources, Inc.
    Date Received
    December 29, 1997
    Decision Date
    February 27, 1998
    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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    Other Clearances by Vancouver Implant Resources, Inc.

    K Number Device Name
    K974857 4.0MM SIMPLER THREADED DENTAL IMPLANT
    K974401 4.0MM SIMPLER ONE THREADED DENTAL IMPLANT
    K974402 3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT
    K974404 4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT
    K974403 3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT