BEUDAMED
    Product Code: DZD FDA class 1 21 CFR 872.5410

    Tube, Orthodontic

    Dental

    The Orthodontic Tube is a dental device, typically a small rectangular or round metal cylinder bonded to a molar tooth, through which an arch wire or facebow is inserted to provide anchorage and control of tooth movement during orthodontic treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZD and the applicable regulation is 21 CFR 872.5410, under the Dental medical specialty.

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    510(k)s
    8
    FEI Numbers
    125
    Registration Numbers
    125
    Unique Applicants
    7
    Years Active
    17

    Basic Information

    Product Code
    DZD
    Device Class
    FDA class 1
    Regulation Number
    872.5410
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K943421 ORTHODONITC ELASTOMERIC SLEEVING
    K936243 REGENCY TUBE
    K935143 DENTAURUM STAINLESS STEEL TUBING
    K911399 NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
    K896586 RATE INCREASE FOR IPPB/IPV
    K834446 ALEXOTEK LINGUAL TUBES
    K834392 LABIAL CUSPID TUBE
    K780205 ORTHODONTIC BUCCAL TUBE

    FEI Numbers

    This FDA classification entry is associated with 125 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.