BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    CANDULOR, AG

    Reg #: 1000277456 · FEI: 1000277456 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    73
    Establishment Types
    5
    Classifications
    9

    Registration Details

    Registration Name
    CANDULOR, AG
    Registration Number
    1000277456
    FEI Number
    1000277456
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Boulevard Lilienthal 8
    City
    Glattpark Zurich
    Country
    CH

    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
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Articulators EJP
    Denture, Plastic, Teeth ELM
    Material, Tooth Shade, Resin EBF
    Teeth, Porcelain ELL
    Facebow KCR
    Crown And Bridge, Temporary, Resin EBG
    Material, Impression Tray, Resin EBH
    Wax, Dental, Intraoral EGD

    Proprietary Names

    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 Articulator CA 3 STRATOS Physiostar NFC Condyloform II NFC SR Modelling Liquid SR Nexco Retention Flow Stains for Resin Teeth finisher SR Nexco SR Nexco Stains SR Nexco Paste SR Nexco Liner SR Nexco Opaquer SR Orthotyp Candulor brands SR Vivodent Preference Posterior SR Ivostar Preference Anterior SR Gnathostar SR Vivodent A-D SR Orthotyp A-D SR Vivoperl Bonartic CT Physioset CT 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 PhysioStar NFC Plus Bonartic II NFC Plus Condyloform II NFC Plus Universal Transferbow System (UTS) CAD Candulor Registration Set CRS-10 Bite Fork Set Bite Fork UNIVERSAL TRANSFERBOW UNIVERSAL TRANSFERBOW SYSTEM (UTS) SR Link SR-IVOLEN TRAY MATERIAL SR-IVOLEN ProArt CAD Try-In PREFERENCE Aesthetic Wax SR ORTHOLINGUAL DCL SR VIVODENT DCL SR Orthotyp DCL Candulor brand denture teeth Candulor Physioset TCR Candulor Bonartic TCR BlueLine SR ORTHOPLANE DCL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Foreign Private Label Distributor Manufacture Medical Device