BEUDAMED
    Product Code: EKF FDA class 1 21 CFR 872.4565

    Instrument, Contouring, Matrix, Operative

    Dental

    The Operative Matrix Contouring Instrument is a hand instrument used to adapt and contour matrix bands around a tooth during placement of restorative materials, ensuring proper proximal contour and contact area for the final restoration. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKF, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    0
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EKF
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.