BEUDAMED
    Product Code: DZJ FDA class 2 21 CFR 872.4120

    Driver, Wire, And Bone Drill, Manual

    Dental

    The Manual Wire and Bone Drill Driver is a dental and oral surgical hand instrument used to manually advance wires into bone or to drive a bone drill without power assistance during oral surgical procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZJ and the applicable regulation is 21 CFR 872.4120, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    32
    FEI Numbers
    47
    Registration Numbers
    47
    Unique Applicants
    26
    Years Active
    50

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    Basic Information

    Product Code
    DZJ
    Device Class
    FDA class 2
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 32 510(k) clearances via K numbers.

    K Number Device Name
    K261826 VSP System (Titanium Palatal Splint)
    K243637 Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
    K242263 TECHFIT DISRP® System
    K231520 tmCMF Solution
    K230276 TECHFIT DISRP® System
    K223024 MedCAD AccuPlan System
    K220366 EmbedMed
    K220648 OMF ASP System
    K212570 OsteoPlan System
    K201353 CenterMed Patient Matched Assisted Surgical Planning (ASP) System
    K193301 coDiagnostiX
    K210347 VSP System
    K193499 DigiGuide System
    K192282 MedCAD® AccuPlan® System
    K181813 ImmersiveView Surgical Plan (IVSP®)
    K192192 VSP System
    K182789 KLS Martin Individual Patient Solutions (IPS) Planning System
    K181241 KLS Martin Individual Patient Solutions (IPS) Planning System
    K172164 PROPEL Device
    K150392 PROPEL device
    K150796 Dental Bone Cutting Instruments
    K133907 VSP SYSTEM
    K120956 VSP SYSTEM
    K040369 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
    K943540 SURGICAL CUTTING BURS
    K915848 SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
    K894151 IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
    K894150 COUNTERBORE FOR SS SUBMERGED SCREW PLANT
    K883922 TECHMEDICA I.B.O. BLADE
    K871834 DRILL, HAND, BONE, SMEDBERG
    K781974 IMPLANT DRIVERS AND TIPS
    K760960 SURGICAL WIRE DRIVER

    FEI Numbers

    This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.