BEUDAMED
    Product Code: EHQ FDA class 1 21 CFR 872.3360

    Cusp, Preformed

    Dental

    The Preformed Cusp is a prefabricated tooth-shaped component, typically of metal or composite material, used by dental laboratory technicians as a base or template to build up or restore a cusp on a dental prosthetic appliance. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHQ, regulated under 21 CFR 872.3360 in the Dental (DE) specialty.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    EHQ
    Device Class
    FDA class 1
    Regulation Number
    872.3360
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.