BEUDAMED
    Product Code: EHM FDA class 1 21 CFR 872.6010

    Strip, Polishing Agent

    Dental

    The Polishing Agent Strip is a narrow, flexible strip coated with abrasive material used to finish and polish interproximal tooth surfaces and restorations in areas where rotary instruments cannot easily reach. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHM, regulated under 21 CFR 872.6010 in the Dental (DE) specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    2
    FEI Numbers
    85
    Registration Numbers
    85
    Unique Applicants
    2
    Years Active
    3

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    Basic Information

    Product Code
    EHM
    Device Class
    FDA class 1
    Regulation Number
    872.6010
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K821364 PROFLEX FLEXIBLE SCALER
    K790598 RUWA FINISHING STRIPS

    FEI Numbers

    This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.