BEUDAMED
    Product Code: QIA FDA class 1 21 CFR 872.6865

    Powered Tongue Scraper

    Dental

    The Powered Tongue Scraper is a dental device intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care. It is classified as FDA Class 1, subject to general controls and exempt from 510(k) premarket notification, regulated under 21 CFR 872.6865 within the Dental medical specialty. The product code is QIA. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

    Research product code QIA in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QIA
    Device Class
    FDA class 1
    Regulation Number
    872.6865
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    Definition

    The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K181986 Klinly Ultrasonic Tongue Cleaner

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.