BEUDAMED
    Product Code: JEO FDA class 1 21 CFR 872.1500

    Measurer, Gingival Fluid

    Dental

    A Gingival Fluid Measurer is a dental diagnostic device used to collect and quantify crevicular fluid from the gingival sulcus, aiding in the assessment of periodontal health and inflammation. It is classified as FDA Class 1 (lowest risk), subject only to general controls such as proper labeling and manufacturing standards. The product code is JEO, regulated under 21 CFR 872.1500, within the Dental medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JEO
    Device Class
    FDA class 1
    Regulation Number
    872.1500
    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 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.