BEUDAMED
    Product Code: EIT FDA class 2 21 CFR 872.3060

    Applicator, Rapid Wax, Dental

    Dental

    The Rapid Wax Applicator is a dental device used to apply softened or melted wax quickly onto study models or working casts during the fabrication of prosthetic appliances, blocking out undercuts or creating wax patterns. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EIT, regulated under 21 CFR 872.3060 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    EIT
    Device Class
    FDA class 2
    Regulation Number
    872.3060
    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

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    Related 510(k) Clearances

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

    K Number Device Name
    K904467 ARGILITE 3

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.