BEUDAMED
    Product Code: EJX FDA class 1 21 CFR 872.3130

    Anchor, Preformed

    Dental

    The Preformed Anchor is a prefabricated metal component used in the construction of removable dental appliances as an attachment mechanism, providing retention and stability by connecting to tooth structure or implant abutments. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJX, regulated under 21 CFR 872.3130 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    EJX
    Device Class
    FDA class 1
    Regulation Number
    872.3130
    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
    K133088 ZX-27

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.