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

    Prestige

    K Number: K151514 · Decision Sep 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    5
    Review Days
    108

    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
    Prestige
    K Number
    K151514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Danville Materials, LLC
    Date Received
    June 5, 2015
    Decision Date
    September 21, 2015
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

    Similar 510(k) Clearances

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

    SRGC-06

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

    FDA 510(k)
    FDA Class 2 ·Dental

    Dual Core

    FDA 510(k)
    FDA Class 2 ·Dental

    Dura-Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    Grandio disc multicolor

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

    Other Clearances by Danville Materials, LLC

    K Number Device Name
    K152349 Star+ VPS Scannable Impression Material
    K151088 DMRC Bulk Fill
    K142886 DMRC Self-Cure Bracket Adhesive One Step and Primer
    K142881 DMRC Dual Cure Orthodontic Band Cement