BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SIRONA DENTAL SYSTEMS GMBH

    Reg #: 9614977 · FEI: 3003719498 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    14
    Establishment Types
    6
    Classifications
    36

    Registration Details

    Registration Name
    SIRONA DENTAL SYSTEMS GMBH
    Registration Number
    9614977
    FEI Number
    3003719498
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FABRIKSTRASSE 31
    City
    BENSHEIM Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K792445

    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

    US Agent

    Business Name
    DENTSPLY SIRONA INC
    Contact Name
    Dan Eagar
    Address
    13320 Ballantyne Corp Pl
    City
    Charlotte
    State
    NC
    ZIP
    28277
    Country
    US
    Email
    [email protected]
    Phone
    704 4926977

    Products

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

    Proprietary Names

    Shorty Handpiece & Motor, Midwest Handpiece, Contra Angle Heads Straight Attachments Rhino Handpiece Midwest RDH Midwest Shorty Single Speed Air Motor Rhino XP Midwest Rhino XP Midwest Shorty Two Speed Air Motor Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Tube Extension Zircon diamond burr set Midwest E mini

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)