BEUDAMED
    Product Code: NFP FDA class 2 21 CFR 872.2050

    Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders

    Dental

    The Device, Dental Sonography, For Diagnosis Of TMJ/MPD Disorders (product code NFP) is a dental diagnostic device that uses sound or ultrasound recording techniques to detect and analyze jaw joint sounds for diagnosing temporomandibular joint (TMJ) or myofascial pain dysfunction (MPD) disorders. It is classified as an FDA Class 2 device within the Dental specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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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
    NFP
    Device Class
    FDA class 2
    Regulation Number
    872.2050
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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