BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.

    Reg #: 1000625496 · FEI: 4838 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    47
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
    Registration Number
    1000625496
    FEI Number
    4838
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    SPITALGASSE 3
    City
    BAD SACKINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K982664

    Owner / Operator

    Firm Name
    VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
    Operator Number
    9052908
    Address
    Spitalgasse 3, --
    City
    BAD SACKINGEN
    State
    Baden-Wurttemberg
    Postal Code
    D-79713
    Country
    DE

    US Agent

    Business Name
    Vita North America
    Contact Name
    Lindsay Tilton
    Address
    22705 Savi Ranch Pkwy, Suite 100
    City
    Yorba Linda
    State
    CA
    ZIP
    92887
    Country
    US
    Email
    [email protected]
    Phone
    925 6999091

    Products

    Device Name Product Code
    Powder, Porcelain EIH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Coating, Filling Material, Resin EBD
    Denture, Plastic, Teeth ELM
    Crown And Bridge, Temporary, Resin EBG
    Point, Abrasive EHL
    Wax, Dental, Intraoral EGD
    Protector, Silicate EFX
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Teeth, Porcelain ELL
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Dentures, Partial NSK
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Titanium VITA Lumex VITA VIONIC BOND Response Akzent LC VITA VIONIC VIGO YZ SHADE LIQUID, YZ EFFECT LIQUID VM7, VM 8, VM9, VM11, VM13, VM15 CAD Temp VITAdur Alpha Ceramic D VITA ENAMIC Polishing Set VITA SUPRINITY® Polishers n!ce Zirconia GT VITA YZ Multi Translucent VITA VIONIC WAX CAD Waxx Omega Omega 800 Omega 900 Celay Blanks Celay Optimizer VITAFol H In-Ceram Alumina VITA ENAMIC Blocks VITAdur-N VMLC Primer Vitablocs, Triluxe, Triluxe Forte VITA SUPRINITY VITA Ambria VITA VIONIC® DENT RESIN VM LC Flow Zeta LC Zeta CC Zeta HC Zeta HLC VM CC VM LC VITA YZ ST and VITA YZ XT VITA YZ ST Multicolor and VITA YZ XT Multicolor VITA VIONIC® BASE RESIN IMPACT Alumina Blanks Spinell Blanks Spinell Optimizer Alumina Optimizer In-Ceram Zirconia VITAchrom-L Interno Akzent, AL Coloring Liquid, YZ Coloring Liquid VITA Vionic Dent Disc Resin Powder Scan Spray VITAPAN, VITAPAN PLUS, VITAPAN EXCELL, VITAPAN CUSPIFORM Vitacoll VITA VMK Master, NP Bond VITA ENAMIC® Implant Solutions (IS) ADIVA F–CEM In-Ceram Spinell PM7 PM9 VMK68 VMK68N VMK95 Hi-Ceram YZ ST & XT SHADE LIQUIDS In-Ceram AL Cube VITA ENAMIC Stains In-Ceram YZ, YZ T and YZ HT

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device