BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTSPLY LLC

    Reg #: 2515379 · FEI: 2515379 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    70
    Establishment Types
    4
    Classifications
    36

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    DENTSPLY LLC
    Registration Number
    2515379
    FEI Number
    2515379
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    38 WEST CLARKE AVENUE
    City
    MILFORD
    State
    DE
    ZIP
    19963
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123215

    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
    Tray, Impression, Preformed EHY
    Sealant, Pit And Fissure, And Conditioner EBC
    Indicator, Physical/Chemical Sterilization Process JOJ
    Sterilant, Medical Devices MED
    Cord, Retraction MVL
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Zinc Oxide Eugenol EMB
    Agent, Tooth Bonding, Resin KLE
    Material, Impression ELW
    Cement, Dental EMA
    Alloy, Amalgam EJJ
    Cleaner, Ultrasonic, Medical Instrument FLG
    Material, Tooth Shade, Resin EBF
    Mouthguard, Prescription MQC
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Post, Root Canal ELR
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Coating, Filling Material, Resin EBD
    Liner, Cavity, Calcium Hydroxide EJK
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Material, Impression Tray, Resin EBH
    Syringe, Restorative And Impression Material EID
    Instrument, Diamond, Dental DZP
    Dental Barriers And Sleeves PEM
    Varnish, Cavity LBH
    Drill, Dental, Intraoral DZA
    Crown And Bridge, Temporary, Resin EBG
    Reamer, Pulp Canal, Endodontic EKP
    Activator, Ultraviolet, For Polymerization EBZ
    Caries Detector, Laser Light, Transmission NTK
    Evacuator, Oral Cavity EHZ
    Disk, Abrasive EHJ
    Paper, Articulation EFH
    Instruments, Dental Hand DZN
    Cleanser, Root Canal KJJ
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    Universal Tray Adhesive MTML Impression Tray Pack HiTray MTM Clear Aligner Patient Case (contains only impression trays, not aligners) Self-Cure GENIE MAGIC MIX ULTRA HYDR Barricaid Perio Dressing Sporox II Cerec Camera Care Kit Esthet-X Improved, Esthet-X Micro Matrix, TPH3 Flow, Esthet-X Easy Twist TPH Improved, Prisma Composite Polishing Paste Tylok Cement Jeltrate Plus Fluorshield VLC Adaptable Composite Resin Delton PLUS Lucitone Digital Print Lucitone Digital Print for Primeprint NUPRO Virtual Intra Oral Tips Oral Tips Mixing Tips Virtual Mixing Tips Virtual Dispenser Intra Oral Tips Zircon diamond burr set Esthet-X Flow TPH Spectra ST SureFil Restorative Delton Opaque Pit & Fissure Sealant Dentin Desensitizer Agent Drills GATES LARGO Integrity Multi-Cure Sample Aquasil Ultra Cordless digit Power Dispenser digit Syringe Dispenser Aquasil Ulta+ Smart Wetting IMpression Material Tooth Conditioner Gel Reprosil Regisil Tray Adhesive Calibra Esthetic Resin Cement XENO IV Palodent Delton FS+ Aquasil Ultra XLV Hydrosil digit Fluorocore II BioPure MTAD Root Canal Cleanser Xeno IV Aquasil Ultra Rigid Delton Clear Pit & Fissure Dycal Calcium Hydroxide Jeltrate Prisma TPH Spectrum NUPRO Sensodyne Prophylaxis Paste with NovaMin NUPRO revolv Silgimix Alginate Replacement Comspan Cement Elite HD+ Putty Soft Digital denture early experience kit Prine & Bond NT DC Nano-Tech Self-Cure Activator

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility