BEUDAMED
    Product Code: EHK FDA class 1 21 CFR 872.6290

    Cup, Prophylaxis

    Dental

    The Prophylaxis Cup is a flexible, rubber or silicone cup-shaped attachment used on a low-speed dental handpiece to apply polishing paste and remove plaque, stains, and soft deposits from tooth surfaces during routine dental cleaning procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHK, regulated under 21 CFR 872.6290 in the Dental (DE) specialty. This device is exempt from GMP requirements.

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    510(k)s
    8
    FEI Numbers
    116
    Registration Numbers
    116
    Unique Applicants
    8
    Years Active
    19

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    Basic Information

    Product Code
    EHK
    Device Class
    FDA class 1
    Regulation Number
    872.6290
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K953628 PROPHY ANGLE
    K951016 DISPOSABLE PROPHYLAXIS ANGLE
    K900507 DISPOSABLE SCREW TYPE PROPHY BRUSH
    K864059 DENTAL PROPHY CUPS (VARIOUS TYPES)
    K803155 PROPHYLAXIS CUP.
    K790723 PROPHYLAXIS CUPS AND POLISHERS
    K780198 PROPHY CUPS, R&R
    K770556 PRO-KUP

    FEI Numbers

    This FDA classification entry is associated with 116 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 116 registration numbers. Click on an entry to view related FDA registrations.