BEUDAMED
    Product Code: NQS FDA class 1 21 CFR 872.5410

    Bracket, Metal, Orthodontic, Reprocessed

    Dental

    The reprocessed metal orthodontic bracket is a dental device affixed to teeth to allow orthodontic forces to be applied via arch wires, enabling tooth movement during orthodontic treatment. It is classified as FDA Class 1 under regulation 872.5410 in the Dental specialty, subject to general controls but not GMP exempt, and requires a 510(k) submission including reprocessing validation data. Product code NQS is eligible for third-party review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NQS
    Device Class
    FDA class 1
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).