BEUDAMED
    Product Code: EHL FDA class 1 21 CFR 872.6010

    Point, Abrasive

    Dental

    The Abrasive Point is a small, tapered or cylindrical dental accessory coated or impregnated with abrasive material, used in conjunction with a rotary handpiece to finish, contour, and polish dental restorations and tooth surfaces. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHL, regulated under 21 CFR 872.6010 in the Dental (DE) specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    4
    FEI Numbers
    80
    Registration Numbers
    80
    Unique Applicants
    2
    Years Active
    2

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    Basic Information

    Product Code
    EHL
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K792250 CUTTER POINTS
    K780811 DENTAL ABRASIVE DEVICE
    K780377 PINIDENTOFLEX DENTAL POLISHER
    K780376 MINIDENTOFLEX NEW POLISHING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 80 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 80 registration numbers. Click on an entry to view related FDA registrations.