BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    NextDent Denture, E-Denture

    K Number: K162572 · Decision Jun 30, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    8
    Review Days
    288

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NextDent Denture, E-Denture
    K Number
    K162572
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vertex-Dental B.V.
    Date Received
    September 15, 2016
    Decision Date
    June 30, 2017
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

    Similar 510(k) Clearances

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

    DB 4000 High Impact Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    Denture Base

    FDA 510(k)
    FDA Class 2 ·Dental

    LuxCreo Flexible Partial Denture Resin

    FDA 510(k)
    FDA Class 2 ·Dental

    TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)

    FDA 510(k)
    FDA Class 2 ·Dental

    UltraPrint-Dental Denture UV

    FDA 510(k)
    FDA Class 2 ·Dental

    Freeprint® denture flex

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

    Other Clearances by Vertex-Dental B.V.

    K Number Device Name
    K241071 NextDent Jet Denture Base; NextDent Jet Denture Teeth
    K231388 NextDent Base
    K221022 NextDent Ortho Flex
    K191497 NextDent Denture 3D+
    K123220 VERTEX THERMOSENS RIGID
    K102640 VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
    K102654 VERTEX RAPID SIMPLIFIED