BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTSPLY SIRONA INC

    Reg #: 3004884150 · FEI: 3004884150 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    35

    Registration Details

    Registration Name
    DENTSPLY SIRONA INC
    Registration Number
    3004884150
    FEI Number
    3004884150
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    221 W Philadelphia St Ste 60w
    City
    York
    State
    PA
    ZIP
    17401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193408

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Dental Abutment Design Software For Dental Laboratory PNP
    Powder, Porcelain EIH
    Activator, Ultraviolet, For Polymerization EBZ
    X-Ray, Tomography, Computed, Dental OAS
    Material, Impression ELW
    Unit, X-Ray, Extraoral With Timer EHD
    Alloy, Metal, Base EJH
    Aligner, Sequential NXC
    Handpiece, Air-Powered, Dental EFB
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY
    System, Image Processing, Radiological LLZ
    Barrier, Animal Source, Intraoral NPL
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Light, Operating, Dental EAZ
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Accessories, Implant, Dental, Endosseous NDP
    Maintainer, Space Preformed, Orthodontic DYT
    Bone Grafting Material, Animal Source NPM
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Unit, Operative Dental EIA
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC
    Caries Detector, Laser Light, Transmission NTK
    Laser, Fluorescence Caries Detection NBL
    Retainer, Screw Expansion, Orthodontic DYJ
    Orthodontic Software PNN
    Controller, Foot, Handpiece And Cord EBW
    Crown And Bridge, Temporary, Resin EBG
    Scaler, Ultrasonic ELC
    Handpiece, Direct Drive, Ac-Powered EKX
    Shield, Eye, Radiological IWS
    Unit, Oral Irrigation EFS
    Material, Impression Tray, Resin EBH

    Proprietary Names

    Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Midwest E mini OSSIX VOLUMAX OSSIX™ Bone Ossix Agile Ossix Breeze OSSIX Plus Tube Extension

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198