BEUDAMED
    Product Code: EKE FDA class 1 21 CFR 872.4565

    Curette, Operative

    Dental

    The Operative Curette is a hand instrument with a spoon-shaped tip used during dental procedures to remove carious tissue, soft debris, or soft tissue from a cavity or surgical site, ensuring a clean surface prior to restoration or healing. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKE, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    0
    FEI Numbers
    43
    Registration Numbers
    43
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    EKE
    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 43 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.