BEUDAMED
    Product Code: EKI FDA class 1 21 CFR 872.4565

    Carrier, Amalgam, Operative

    Dental

    The Amalgam Carrier is a dental instrument used to transport measured amounts of freshly mixed amalgam alloy from the capsule to the prepared tooth cavity, typically featuring a plunger mechanism to express the material into the preparation. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKI, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.

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    510(k)s
    2
    FEI Numbers
    91
    Registration Numbers
    91
    Unique Applicants
    2
    Years Active
    17

    Basic Information

    Product Code
    EKI
    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

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K945220 AMALGAM CARRIER
    K781034 PREMIER INLAY PLACER

    FEI Numbers

    This FDA classification entry is associated with 91 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 91 registration numbers. Click on an entry to view related FDA registrations.