BEUDAMED
    Product Code: PIP FDA class 2 21 CFR 872.6080

    Prophy Powder, Airbrush Accessory

    Dental

    The Prophy Powder Airbrush Accessory is a dental air polishing powder used with an airbrush handpiece for oral prophylaxis, helping to remove stains, plaque, and biofilm from tooth surfaces. It is an FDA Class 2 device regulated under 21 CFR 872.6080, requiring 510(k) clearance, within the Dental (DE) medical specialty. The product code is PIP, and it is eligible for third-party review. This device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    1

    Basic Information

    Product Code
    PIP
    Device Class
    FDA class 2
    Regulation Number
    872.6080
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An air polishing powder to be used with an airbrush for prophylaxis in the oral cavity.

    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
    K151748 Clean & More
    K140684 CLINPRO PROPHY POWDER

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.