BEUDAMED
    Product Code: EGI FDA class 1 21 CFR 872.4565

    Parallelometer

    Dental

    The Parallelometer (surveyor) is a dental laboratory instrument used to analyze the geometry of a dental cast and to determine the path of insertion for a removable partial denture, ensuring that all components can be placed and removed without interference. 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 EGI and the applicable regulation is 21 CFR 872.4565, under the Dental medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    EGI
    Device Class
    FDA class 1
    Regulation Number
    872.4565
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K801853 PARALLEL-A-PREP

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.