BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTSPLY LLC

    Reg #: 2424472 · FEI: 3002088145 · Expires 2026
    View on FDA
    Products
    41
    Proprietary Names
    107
    Establishment Types
    5
    Classifications
    41

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    Registration Details

    Registration Name
    DENTSPLY LLC
    Registration Number
    2424472
    FEI Number
    3002088145
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1301 SMILE WAY
    City
    York
    State
    PA
    ZIP
    17404
    Country
    US

    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

    Products

    Device Name Product Code
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Scaler, Ultrasonic ELC
    Unit, X-Ray, Intraoral EAP
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Powder, Porcelain EIH
    Aligner, Beam, X-Ray EHA
    Dental Barriers And Sleeves PEM
    Holder, Film, X-Ray EGZ
    Collimator, Manual, Radiographic IZX
    Sealant, Pit And Fissure, And Conditioner EBC
    Sterilant, Medical Devices MED
    Indicator, Physical/Chemical Sterilization Process JOJ
    Handpiece, Direct Drive, Ac-Powered EKX
    Material, Tooth Shade, Resin EBF
    Dispenser, Liquid Medication KYX
    Coating, Filling Material, Resin EBD
    Agent, Tooth Bonding, Resin KLE
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Cleanser, Denture, Over The Counter EFT
    Illuminator, Radiographic-Film IXC
    Needle, Dental DZM
    Preparer, Root Canal Endodontic EKQ
    Mask, Surgical FXX
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Airbrush KOJ
    Unit, Syringe, Air And/Or Water ECB
    Varnish, Cavity LBH
    Orthodontic Vibratory Accessory OYH
    Evacuator, Oral Cavity EHZ
    System, X-Ray, Extraoral Source, Digital MUH
    Amalgamator, Dental, Ac-Powered EFD
    Cup, Prophylaxis EHK
    General Purpose Dental Tray OFX
    Phantom, Anthropomorphic, Radiographic IXG
    Unit, X-Ray, Extraoral With Timer EHD
    Handle, Instrument, Dental EJB
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Crown And Bridge, Temporary, Resin EBG
    Denture, Plastic, Teeth ELM
    Articulators EJP
    Cleaner, Ultrasonic, Medical Instrument FLG

    Proprietary Names

    Shorty Handpiece & Motor, Midwest Handpiece, Contra Angle Heads Straight Attachments Rhino Handpiece Midwest RDH SofScale XCP-DS® Sensor Holder X-Ray Exposure Alignment (XCP® / XCP-ORA®) Uni-GRIPAR® 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 Snap-A-Ray® Film Holder Uni-Grip® Universal Radiography Holder BAI Bite-Block film holders Rinn Digital Sensor Covers Flip-Ray XCP-DS FIT® Sensor Holder Rinn® Digital Sensor Loops XCP-DS® Digital Sensor Replacement Baskets and Bite Blocks XCP-DS® Replacement Bitepieces Uni-Grip® 360 Universal Sensor Holder Eezee-Grip® Digital Sensor Holder Silicone BW #2 Film Holder EndoRay® II Endodontic Film Holder Snap-A-Ray® DS for Sensors XCP® / XCP-ORA® Film Positioning Kits Adhesive Comfort Tab for Film -Cover Cozee® BAI Instrument Kits Bite-Wing Loops film holders Bite-Wing Instrument Kits RINN® XCP-ORA® Cover Cozee Sensor Cover Tamer XCP® Disposable Bite-Blocks (film holders) Bite-Wing Bite-Blocks film holders Uni-Bite® Universal Film Holder Cover Cozee Comfort Solution XCP-DS® Digital Sensor Positioning Kits Rinn® Loops Schick CDR Elite Sensor Holder Cover Cozee BW Rinn® Cover-Cozee® Sensor Cover Tamer Stabe® Disposable Film Holders Adhesive Bite-Wing Tabs XCP®, BAI & XCP-DS® Stainless Steel Indicator Arms Ceramco 3 Enamel, Excelsior Porcelain, Delton Pit & Fissure Sealant, Sporox II Cerec Camera Care Kit RINN XCP-DS FIT Genios Teeth Ceramco 3 C3 SofTip Dispos Prophy Tip Bobcat PRO Ultrasonic Scaler, Inserts, EZ Auto Light Flatscreen Viewer Universal Countertop/Wall Mount Film Viewers Jenker Needle Stick Protector NUPRO Sensodyne Prophylaxis Paste with NovaMin Colorlogic Edge Shoulder Ceramco I Cermaco II Ceramco 3 JET-Fresh Prophy Powder FLASHTIPS Delton Clear Pit & Fissure Delton FS+ Lucitone Digital Print Delton PLUS Aquasil Ultra Cordless digit Power Dispenser digit Syringe Dispenser Prophy Jet Air Polishing System, JetShield Assembly, Prophy Jet Sheath Delton Opaque Pit & Fissure Sealant Digital denture early experience kit Hurrimix Modulmix Elite Mix Hurrimix 2 Tooth Conditioner Gel NUPRO DXTTR Cavitron SPS, Slimline Inserts Focused Spray Inserts, Cavitron JET SPS, Prophy-Jet Powder NUPRO revolv Dental Tools Quattro Porcelain System Lucitone Digital Print for Primeprint Genios Sani-Tip

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)