BEUDAMED
    Product Code: QRQ FDA class 1 21 CFR 872.3980

    Non-Irrigation Endosseous Dental Implant Drill Bits

    Dental

    The Non-Irrigation Endosseous Dental Implant Drill Bits are surgical instruments designed to prepare the alveolar bone site for placement of endosseous dental implants, operated at low speed and without irrigation fluid. The absence of irrigation distinguishes these drill bits from standard implant drills. Classified as FDA Class 1 under regulation 872.3980 in the Dental specialty, these devices are subject only to general controls and are exempt from 510(k) premarket notification requirements. They are not implants and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QRQ
    Device Class
    FDA class 1
    Regulation Number
    872.3980
    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 prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.