BEUDAMED
    Product Code: NRD FDA class 1 21 CFR 872.6640

    Unit, Operative Dental, Accessories

    Dental

    Operative Dental Unit Accessories include air compressors and vacuum units connected to dental operative units to provide compressed air and vacuum capability for powering and driving other attached dental devices. These accessories are essential supporting components of the dental operatory setup and are classified as FDA Class 1 devices under 21 CFR 872.6640, subject to general controls. The product code is NRD, falling within the Dental medical specialty. These devices are exempt from premarket notification (510(k)) and do not carry implant or life-sustaining support designations.

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    510(k)s
    2
    FEI Numbers
    139
    Registration Numbers
    139
    Unique Applicants
    2
    Years Active
    3

    Basic Information

    Product Code
    NRD
    Device Class
    FDA class 1
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    Definition

    Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.

    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
    K072273 BELMONT QUOLIS 5000 SERIES DENTAL UNIT
    K042266 ACCLAIM

    FEI Numbers

    This FDA classification entry is associated with 139 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 139 registration numbers. Click on an entry to view related FDA registrations.