BEUDAMED
    Product Code: NYC FDA class 1 21 CFR 872.4565

    Dental Prophylaxis Kit

    Dental

    The Dental Prophylaxis Kit (product code NYC) is a Class 1 dental convenience kit established under the May 1997 Convenience Kits Interim Regulatory Guidance, regulated under 21 CFR 872.4565 within the Dental specialty. It is under enforcement discretion and does not require a 510(k) premarket notification to market if all guidance criteria are met. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NYC
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    7

    Device Characteristics

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

    Definition

    This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.