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

    PS3 TITANIUM SCREW DENTAL IMPLANT

    K Number: K800762 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    PS3 TITANIUM SCREW DENTAL IMPLANT
    K Number
    K800762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Colmed, Ltd.
    Date Received
    April 7, 1980
    Decision Date
    May 14, 1980
    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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