BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    DENTSPLY IH BV

    Reg #: 3011824442 · FEI: 3011824442 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    41

    Registration Details

    Registration Name
    DENTSPLY IH BV
    Registration Number
    3011824442
    FEI Number
    3011824442
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Piri Reisweg 23
    City
    Sevenum Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K921479

    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
    Powder, Porcelain EIH
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Agent, Tooth Bonding, Resin KLE
    Alloy, Gold-Based Noble Metal EJT
    Material, Tooth Shade, Resin EBF
    Instrument, Cutting, Operative EKD
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Sterilizer, Steam FLE
    Controller, Foot, Handpiece And Cord EBW
    Tray, Surgical, Instrument FSM
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Plate, Bone JEY
    Locator, Root Apex LQY
    Handpiece, Direct Drive, Ac-Powered EKX
    Unit, Oral Irrigation EFS
    Activator, Ultraviolet, For Polymerization EBZ
    Handpiece, Rotary Bone Cutting KMW
    Preparer, Root Canal Endodontic EKQ
    Bone Grafting Material, Synthetic LYC
    System, Image Processing, Radiological LLZ
    Dental Abutment Design Software For Dental Laboratory PNP
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Punch, Biopsy, Surgical EME
    Instruments, Dental Hand DZN
    Accessories, Implant, Dental, Endosseous NDP
    Dental Barriers And Sleeves PEM
    Operating Room Accessories Table Tray FWZ
    Resin, Root Canal Filling KIF
    Alloy, Metal, Base EJH
    Bone Grafting Material, Animal Source NPM
    Barrier, Animal Source, Intraoral NPL
    Applicator, Resin KXR
    Cement, Dental EMA
    Chair, Dental, Without Operative Unit NRU
    Point, Paper, Endodontic EKN
    Chisel, Osteotome, Surgical EMM
    Broach, Endodontic EKW
    Anchor, Preformed EJX
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    LFC Cercon Abutments Ankylos Cercon Balance Option Cerec Essentials Materials Starter Kit Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit Tube Extension Contra-angle Dental Abutment/Implant Duceram Kiss Porcelain Duceram Plus Porcelain XiVe TG Ankylos Temporary Abutment Balance Washtray Sterilization Container Implant Universal Body Stain Universal Stain Celtra Ceram Universal Incisal Stain Dentsply Sirona Universal Overglaze CELTRA Duo Dentsply Sirona Universal Incisal Stain Dentsply Sirona Universal Body Stain Universal Overglaze-High Flu Dentsply Sirona Universal Stain & Overglaze Kit Dentsply Sirona Universal Stain Dentsply Sirona Universal Overglaze-High Flu Universal Overglaze TPH Spectra ST Adaptable Composite Resin Tylok Cement Caulk Post & Core Kit Paper Points EsthetiCap Shaded PMMA VIPI BLOCK PMMA Disks Multilayer PMMA PrimeTaper Duceragold Kiss

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device