BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Retraxil

    K Number: K243910 · Decision Sep 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    7
    Review Days
    279

    Basic Information

    Device Name
    Retraxil
    K Number
    K243910
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kulzer, LLC
    Date Received
    December 19, 2024
    Decision Date
    September 24, 2025
    Product Code
    MVL
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVL Cord, Retraction

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MVL), ordered by most recent decision date.

    CyClean Cord

    FDA 510(k)
    FDA Unclassified ·Unknown

    One-Stop

    FDA 510(k)
    FDA Unclassified ·Unknown

    Stasis Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    Gingi-Aid Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    VOCO Retraction Paste

    FDA 510(k)
    FDA Unclassified ·Unknown

    STATSTIX

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Kulzer, LLC

    K Number Device Name
    K260783 Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
    K254063 iCEM Universal Plus
    K240660 Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
    K233868 dima Print Teeth & Temp
    K230644 Signum opaque F
    K220605 Venus Bulk Flow ONE