BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Nexus Universal Self-Cure

    K Number: K191548 · Decision Oct 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    495
    Applicant Total
    6
    Review Days
    121

    Basic Information

    Device Name
    Nexus Universal Self-Cure
    K Number
    K191548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerr Corporation
    Date Received
    June 12, 2019
    Decision Date
    October 11, 2019
    Product Code
    EMA
    Advisory Committee
    Dental
    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
    EMA Cement, Dental

    Similar 510(k) Clearances

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

    Choice 2 DC

    FDA 510(k)
    FDA Class 2 ·Dental

    ResiCem EX

    FDA 510(k)
    FDA Class 2 ·Dental

    EsCem RMGI

    FDA 510(k)
    FDA Class 2 ·Dental

    OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Insure® Universal; Insure® Universal Automix

    FDA 510(k)
    FDA Class 2 ·Dental

    TopCEM-Veneer Light Cure Veneer Cement

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Kerr Corporation

    K Number Device Name
    K222830 Rainbow 360
    K221255 SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
    K182162 OptiBond eXTRa Universal
    K162436 EndoVac Pure
    K162257 P1145 Dental Restorative