BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    VERTEX-DENTAL B.V.

    Reg #: 8030452 · FEI: 3003943714 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    VERTEX-DENTAL B.V.
    Registration Number
    8030452
    FEI Number
    3003943714
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Centurionbaan 190
    City
    Soesterberg Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K102654

    Owner / Operator

    Firm Name
    Vertex-Dental B.V.
    Operator Number
    8030452
    Address
    Centurionbaan 190
    City
    Soesterberg
    State
    Utrecht
    Postal Code
    3769AV
    Country
    NL

    US Agent

    Business Name
    Qserve Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Maintainer, Space Preformed, Orthodontic DYT
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Material, Impression Tray, Resin EBH
    Material, Tooth Shade, Resin EBF
    Plate, Base, Shellac EEA
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY
    Accessories, Implant, Dental, Endosseous NDP
    Teeth, Artificial, Posterior With Metal Insert ELJ
    Teeth, Artificial, Backing And Facing ELK

    Proprietary Names

    NextDent Ortho Rigid E-Guard NextDent Ortho Clear Dental LT Clear Ceramill Ortho Rigid Ceramill Ortho Flex NextDent Ortho Flex Implacryl Rapid Simplified Castavaria Castapress Self-Curing NextDent Jet Base NextDent Jet Teeth NextDent Base NextDent Denture Thermodent (Confidential) NextDent Tray NextDent Ortho IBT E-IDB Ceramill Tray Ceramill Ortho IBT Vertex Trayplast Saremco Print Crowntec NextDent Try-In Ceramill Try-In NextDent Denture 3D+ Ceramill Denture 3D+ NextDent SG E-Guide Tint Dental SG Ceramill SG NextDent C&B NextDent C&B MFH E-Dent 400 Ceramill C&B MFH

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device