BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COSMEDENT, INC.

    Reg #: 1450653 · FEI: 1450653 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    54
    Establishment Types
    1
    Classifications
    24

    Registration Details

    Registration Name
    COSMEDENT, INC.
    Registration Number
    1450653
    FEI Number
    1450653
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4646 N. RAVENSWOOD AVE.
    City
    CHICAGO
    State
    IL
    ZIP
    60640
    Country
    US

    Regulatory Submissions

    510(k) Number
    K854755

    Owner / Operator

    Firm Name
    COSMEDENT, INC.
    Operator Number
    1450653
    Address
    401 NORTH MICHIGAN AVE., SUITE 2500
    City
    Chicago
    State
    IL
    Postal Code
    60611
    Country
    US
    Correspondent
    MICHAEL - O'MALLEY

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Coating, Filling Material, Resin EBD
    Applicator, Resin KXR
    Strip, Polishing Agent EHM
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Crown And Bridge, Temporary, Resin EBG
    Sealant, Pit And Fissure, And Conditioner EBC
    Agent, Tooth Bonding, Resin KLE
    Material, Impression ELW
    Eraser, Dental Stain MAU
    Tray, Impression, Preformed EHY
    Cement, Dental EMA
    Varnish, Cavity LBH
    Retainer, Matrix JEP
    Dispenser, Mercury And/Or Alloy EHE
    Point, Abrasive EHL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Syringe, Restorative And Impression Material EID
    Wheel, Polishing Agent EJQ
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Cup, Prophylaxis EHK
    Disk, Abrasive EHJ
    Tray, Surgical, Instrument FSM
    Handle, Instrument, Dental EJB

    Proprietary Names

    Renamel Microfill Creative Color Renamel Gingafill Renamel Flowable Microfill Renamel Posterior Occlusal Cosmedent Brushes FlexiStrip CompositeEtch MirrorImage CosmeCore Renamel® NANO™ +plus PorcelEtch Renamel Posterior Body Complete Unfilled Resin Kwik Cosmedent Easywhite RSVP Impression Tray Upper RSVP Impression Tray Lower RSVP Light Body Complete Primer/Unfilled Resin Brush and Sculpt Complete Dual-Cure Catalyst CosmeSeal Desensitizer CosmeTemp Matrix Bands Compule Gun GingaGuard All Ceramic Polishers FlexiPoints MASS SPECTROMETRY MONITORING LINE CONONECTORS Tips Oxygone da Vinci Insure Finishing Mandrels Impressiv Enamelize FlexiCups Renamel Flowable Microhybrid Renamel Microhybrid Show-Off RSVP Heavy Body Porcelize FlexiWheel FlexiDisc Silanator Renamel NANO E-Z Temp Instrument Tray Prevue BulkFill Renamel® De-Mark™ Composite Pacement Instruments

    Establishment Types

    Repack or Relabel Medical Device