BEUDAMED
    Product Code: JEP FDA class 1 21 CFR 872.4565

    Retainer, Matrix

    Dental

    A Matrix Retainer is a dental instrument used to hold a matrix band around a tooth during the placement of restorative materials such as composite resin or amalgam, helping to create a proper contour and contact for the restoration. It is classified as FDA Class 1 (lowest risk), governed by general controls only. The product code is JEP, regulated under 21 CFR 872.4565, within the Dental medical specialty. No special flags apply to this device.

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    510(k)s
    3
    FEI Numbers
    108
    Registration Numbers
    108
    Unique Applicants
    3
    Years Active
    26

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    Basic Information

    Product Code
    JEP
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K091533 SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
    K930151 OMNI-MATRIX
    K831136 DOUBLE BOW TOOTH SEPARATOR

    FEI Numbers

    This FDA classification entry is associated with 108 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 108 registration numbers. Click on an entry to view related FDA registrations.