BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Candulor Dental GmbH

    Reg #: 3011511773 · FEI: 3011511773 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    9

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    Registration Details

    Registration Name
    Candulor Dental GmbH
    Registration Number
    3011511773
    FEI Number
    3011511773
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Riederngraben 6
    City
    Rielasingen-Worblingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K913655

    Owner / Operator

    Firm Name
    IVOCLAR VIVADENT
    Operator Number
    8010208
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    Postal Code
    14228
    Country
    US
    Correspondent
    Dana Glina

    US Agent

    Business Name
    Ivoclar Vivadent
    Contact Name
    Anderjeet Gulati
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    ZIP
    14228
    Country
    US
    Email
    [email protected]
    Phone
    716 2642046

    Products

    Device Name Product Code
    Articulators EJP
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Teeth, Porcelain ELL
    Gauge, Depth, Instrument, Dental EIL
    Material, Impression Tray, Resin EBH
    Material, Tooth Shade, Resin EBF
    Crown And Bridge, Temporary, Resin EBG
    Facebow KCR
    Denture, Plastic, Teeth ELM

    Proprietary Names

    Articulator CA 3 STRATOS BasePlast Fibers AutoPlast Monomer BasePlast Monomer BasePlast Polymer Aesthetic Intensiv Color AutoPlast AutoPlast Polymer Triplex Cold Triplex Hot Aesthetic Cold Probase High Impact Hot XPLEX Probase Hot Probase Cold Aesthetic Hot Probase High Impact Cold SR Vivoperl Bonartic CT Physioset CT Rim Former New Bite Gauge Bite Plane SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In SR Link Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) PREFERENCE SR Vivodent S PE SR Orthotyp S PE SR Vivodent S DCL SR Orthotyp S DCL SR Ortholingual S DCL PhysioSelect TCR BonSelect TCR Ivotion Dent SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D Physiostar NFC Condyloform II NFC SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility