BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Dentsply IH AB

    Reg #: 9612468 · FEI: 3002806429 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    8
    Establishment Types
    5
    Classifications
    11

    Registration Details

    Registration Name
    Dentsply IH AB
    Registration Number
    9612468
    FEI Number
    3002806429
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HELIUMGATAN 1
    City
    MOLNDAL Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K250081

    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
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Instrument, Cutting, Operative EKD
    Plate, Bone JEY
    Hearing Aid, Bone Conduction LXB
    Powder, Porcelain EIH
    Crown, Preformed ELZ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Hearing Aid, Bone Conduction, Implanted MAH
    Accessories, Implant, Dental, Endosseous NDP
    Chisel, Osteotome, Surgical EMM

    Proprietary Names

    Implant Dental Abutment/Implant Ankylos Temporary Abutment Balance ATLANTIS™ Crown EsthetiCap Atlantis Temp Crown PrimeTaper XiVe TG

    Establishment Types

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