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

    IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT

    K Number: K894151 · Decision Sep 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    31
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
    K Number
    K894151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Artech Corp.
    Date Received
    June 14, 1989
    Decision Date
    September 27, 1989
    Product Code
    DZJ
    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
    DZJ Driver, Wire, And Bone Drill, Manual

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    Other Clearances by Artech Corp.

    K Number Device Name
    K911735 ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT
    K895267 ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT
    K891346 ARTECH TYPE SS SUBMERGED SCREW IMPLANT
    K894160 HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL
    K894150 COUNTERBORE FOR SS SUBMERGED SCREW PLANT
    K843217 HOLLOW BASKET DENTAL IMPLANTS
    K843218 TPS SCREW DENTAL IMPLANTS