BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DELTAMED GMBH

    Reg #: 3002789526 · FEI: 3002789526 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    56
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    DELTAMED GMBH
    Registration Number
    3002789526
    FEI Number
    3002789526
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    RAIFFEISENSTR. 8a
    City
    FRIEDBERG Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K222435

    Owner / Operator

    Firm Name
    DELTAMED GMBH
    Operator Number
    9026386
    Address
    RAIFFEISENSTR. 8a, --
    City
    FRIEDBERG
    State
    Hesse
    Postal Code
    61169
    Country
    DE

    US Agent

    Business Name
    COSMEDENT, INC.
    Contact Name
    Mary Beth Nowak
    Address
    401 NORTH MICHIGAN AVE., SUITE 2500
    City
    CHICAGO
    State
    IL
    ZIP
    60611
    Country
    US
    Email
    [email protected]
    Phone
    800 6216729

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Cement, Dental EMA
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Maintainer, Space Preformed, Orthodontic DYT
    Sealant, Pit And Fissure, And Conditioner EBC
    Plate, Base, Shellac EEA
    Accessories, Implant, Dental, Endosseous NDP
    Agent, Tooth Bonding, Resin KLE
    Material, Impression Tray, Resin EBH
    Mouthguard, Prescription MQC
    Coating, Filling Material, Resin EBD
    Agent, Polishing, Abrasive, Oral Cavity EJR

    Proprietary Names

    Renamel® Flowable Microhybrid Renamel® Microhybrid 3Delta Crown PRO Resins Crown X 3Delta Denture Teeth PRO Resins Tooth X Prevue® PRO Resins Arch X RS VIVO C&B Ultimate 3Delta UNlimited Insure® Lite Insure® Lite Automix Insure® P pro Crown & Bridge 3Delta Etemp Renamel® Gingafill® Creative Color® Pink Opaque™ Creative Color® Tint Creative Color® Clear Liquid Resin Creative Color® Opaquer P pro Splint COSMESEAL® Clear COSMESEAL® Filled Renamel® Microfill P pro Try-In RS VIVO Try-In 3Delta Try-In XT Renamel® NANO™ +plus PRO Resins Guide X P Pro Surgical Guide Clear 3Delta Guide XT RS VIVO Guide Brush & Sculpt™ Renamel® Bulkfill 3Delta Denture Fix 3Delta Denture Bond 3Delta Denture Base PRO Resins Base X PRO Resins Denture Fix ACRIFIX Bonder PRO Resins Denture Bond RS VIVO Tray RS Impression Tray P pro Impression Tray Green 3 Delta Tray 3Delta Tray Rose Insure® UNIVERSAL Insure® UNIVERSAL AutoMix Renamel® De-Mark™ Renamel® Flowable Microfill Insure® Silanator Enamelize™ ACRIFIX rosa/pink Set ACRIFIX rosa/pink ACRIFIX rosa-opak CosmeCore™

    Establishment Types

    Manufacture Medical Device