BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultradent Products Inc.

    Reg #: 1718912 · FEI: 1718912 · Expires 2026
    View on FDA
    Products
    47
    Proprietary Names
    220
    Establishment Types
    3
    Classifications
    47

    Registration Details

    Registration Name
    Ultradent Products Inc.
    Registration Number
    1718912
    FEI Number
    1718912
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    505 W Ultradent Dr (10200 South)
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970113

    Owner / Operator

    Firm Name
    ULTRADENT PRODUCTS, INC.
    Operator Number
    1718962
    Address
    505 West Ultradent Drive (10200 South), --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    Products

    Device Name Product Code
    Liner, Cavity, Calcium Hydroxide EJK
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Material, Tooth Shade, Resin EBF
    Scaler, Ultrasonic ELC
    Burnisher, Operative EKJ
    Cement, Dental EMA
    Crown And Bridge, Temporary, Resin EBG
    Agent, Tooth Bonding, Resin KLE
    Gutta-Percha EKM
    Sealant, Pit And Fissure, And Conditioner EBC
    Floss, Dental JES
    Material, Impression ELW
    Varnish, Cavity LBH
    Resin, Root Canal Filling KIF
    Applicator, Resin KXR
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Pick, Massaging JET
    Cord, Retraction MVL
    Cleanser, Root Canal KJJ
    Accessory, Surgical Apparel LYU
    Activator, Ultraviolet, For Polymerization EBZ
    Accessories To Examination Light PEQ
    Detector, Ultraviolet EAQ
    Post, Root Canal ELR
    Material, Impression Tray, Resin EBH
    Instruments, Dental Hand DZN
    Dental Barriers And Sleeves PEM
    Powder, Porcelain EIH
    Retainer, Matrix JEP
    Handpiece, Air-Powered, Dental EFB
    Device, Caries Detection LFC
    Retractor, All Types EIG
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Bur, Dental EJL
    Instrument, Filling, Plastic, Dental EIY
    Strip, Polishing Agent EHM
    Disk, Abrasive EHJ
    Evacuator, Oral Cavity EHZ
    Dam, Rubber EIE
    Wheel, Polishing Agent EJQ
    Wax, Dental, Intraoral EGD
    Cup, Prophylaxis EHK
    Syringe, Restorative And Impression Material EID
    Handpiece, Direct Drive, Ac-Powered EKX
    Handle, Instrument, Dental EJB
    Bracket, Plastic, Orthodontic DYW

    Proprietary Names

    UltraBlend Plus Ease-In-Shields PermaSeal Ultrawave Bottle cap SYRINGE COVERS PermaShade LC Light Cure Veneer Cement PermaShade Try-In Paste ExperTemp Mosaic Universal Composite UltraTemp Peak SE Vit-l-escence EndoREZ Points Endo-Eze™ Genius™ Gutta Percha PrimaDry UltraPak Kit UltraPak Thermo Clone VPS Medium Body and Fast Set Medium Body & Heavy Body and Fast Set Heavy Body Thermo Clone VPS Putty Fast Set Consepsis V Consepsis Silane PermaFlo DC Black Mini Brush Tips Inspiral Brush Tips Opal Red Tips Opal Seal Tips Ultrapro Tx Prophy Paste OPALUSTRE UltraCEM Resin Reinforced Glass Lonomer Luting Cement OPAL PIX Ultrapak E Knitted Cord Amelogen Plus Chromaclone 5 Day Stability File_Eze EDTA Lubricant UltraEZ DeOx UltraTect Protective Eyewear Clone Bite VALO Grand Valo Grand Accessory(battery charger,rechargeable batteries,light shield,bracket holder,charging unit power supply,etc.) VALO TransLume Lens, VALO Grand TransLume Lens VALO ProxiCure Ball Lens, VALO Grand ProxiCure Ball Lens VALO Grand White Light Lens VALO Black Light Lens, VALO Grand Black Light Lens VALO PointCure Lens, VALO Grand PointCure Lens VALO Interproximal Lens, VALO Grand Interproximal Lens MTApex Bioceramic Root Canal Sealer UniCore Post UniCore Accessory Posts ULTRADENT LC BLOCK-OUT RESIN Emiluma UltraCal XS ViscoStat Clear Thermo Clone VPS Fast Alginate Alternative 380 ml Kit Thermo Clone VPS Alginate Alternative 10x50 ml Bulk Pack Thermo Clone VPS Alginate Alternative 2x50 ml Kit ExperTemp Dispensing Gun Impression Dispensing Gun Ultradent Micro Applicators Quad Key Micro Applicators Enamelast Application Brushes INTERGUARD Ultradent Composite Gun EDTA 18% Solution Ultrapro Tx Cordless Prophy Motor Barrier Sleeves Porcelain Etch EtchArrest Ultradent Porcelain Repair Kit Opal Seal Composite Wetting Resin Transcend Peak-ZM Chromaclone PVS Putty Chromaclone PVS (Fast Set) Chromaclone PVS (Reg. Set) Omni-Matrix Winged Omni-Matrix Wingless Omni-Matrix Sectional Omni-Matrix Original Wingless Omni-Matrix Original Winged Halo Sectional Matrix Ring Halo Sectional Matrix Bands Halo Sectional Matrix Wedges Halo Sectional Non-Stick Matrix Bands Ultrapro TX Air Motor and Nose Cones Ultrapro Tx Air Hygiene Handpiece UltraSeal XT hydro EndoREZ Accelerator EndoREZ Dual Cure EndoREZ Obturation Kit Sable Seek Seek ChlorCid V ChlorCid Surf ChlorCid Thermo Clone VPS Fast Set Superlight Body Thermo Clone VPS Fast Set Bite Registration Thermo Clone VPS Clear Bite Registration Fast Set OpalDam OpalDam Green OT Gingival Barrier UltraSeal XT™ plus bioprotection by Nobio UltraSeal XT™ hydro bioprotection by Nobio 1.2 mL Plastic Syringe Endo-Eze Tips Capillary Tips Endo-Eze Irrig. Tips Micro Capillary Tips 5 mL Plastic Syringe Skini Syringes NaviTip FX Tips Micro 20g tips NaviTip TriAway Adaptor Ultradent Syringe Covers SST Surgical Suction Tip Deliver-Eze Irrig. & Evac. Kit Hemostatic Delivery Syringes Unicore Drill Ultradent Comp. Finishing Bur Kit PQ1 Opal Bond Flow Ultra-Etch Opal Etch Opal Bond MV Consepsis Scrub Peak Universal Bond Black Micro FX Tips SoftEZ Tips JIffy Diamond Strips JIFFY PROXIMAL SAW-FINISH Jiffy Polishing Disks (F, M, C) Jiffy HiShine Disks JIFFY DISKS Jiffy Polishing Cups (F, M, C) Jiffy HiShine Cups JIFFY CUPS JIFFY POINTS Ultradent Luer Vacuum Adapter Universal Dentin Sealant PropGuard Sof-Tray Classic Sheets IsoBlock Umbrella Cheek Retractor OralSeal Kit OralSeal Putty OraSeal Caulking Jiffy Composite Pol. Brush (ptd) Jiffy Composite Pol. Brush (reg) Jiffy Goat Hair Brush StarBrush VALO Cordless Barrier Sleeve VALO GRAND Barrier Sleeve VALO Corded Barrier Sleeve VALO VALO Accessory (16' cord Power Supply) Valo Corded Accessory (light shield, lenses, blocking glassses, bracket holder, charging unit power supply etc. VALO ORTHO Gishy Goo PermaFlo PermaFlo Pink PermaFlo Purple UltraSeal XT Plus Enamelast Gleo Varnish Opal Cups, Bristle Opal Cups, Finishing VALO XG Colors VALO XG Color Loaners VALO XS Color Loaners VALO XS Demo Unit Colors VALO X Accessories (Assembled Cord, Power Supply, Battery Charger, Batteries) VALO X Accessory Lenses (PointCure Lens, ProxiCure Ball Lens, Diffuser Lens, Interproximal Lens, TransLume Lens) VALO X VALO X Colors VALO X Demo Unit Colors VALO X Color Loaners VALO XG Demo Unit Colors VALO XS Colors Lumaloc Opal Band Cement Luer Lock Caps Black Mini Tips Blue Micro Tips Mixing Tips Black Micro Tips Thermo Clone VPS Dynamic Mixer Micro 20g FX Tips Dento-Infusor Tips Expertemp Mixing Tips IntraOral Impression Tips 3 mL Impression Syringe Opal Bond Flow Tip Blue Mini Tips Chromaclone PVS Mixing Tips Opal Band Mixing Tips IntraOral Tip White Mac Tips White Mini Tips Metal Dento-Infusor Tip with Comfort Hub Clear Temp Ultrapro Tx Cordless Prophy Motor Kit Chromaclone Putty VALO Grand Corded Ultradent Slide Packer Fischer's Ultrapak Packer Halo Sectional Matrix Forceps Halo Sectional Matrix Tweezers J-Temp Citric Acid 20% VALO Ortho Cordless VALO Cordless VALO Cordless Accessory(Battery Charger,Rechargeable Batteries,Light Shield,Bracket Holder,Charging Unit Power Supply) Forma S UltraTemp REZ II Ultradent Diamond Polish Mint Opal Bond Chromaclone Ortho 5 Day Stability

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)