Ultradent Products Inc.

FDA Device Registration & Listing · South Jordan, UT, US · Registration 1718912

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1718912
FEI Number
1718912
Entity Name
Ultradent Products Inc.
City/State/Country
South Jordan, UT, US
Establishment Address
505 W Ultradent Dr (10200 South), South Jordan, UT 84095, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ULTRADENT PRODUCTS, INC. (Owner Number: 1718962)
Owner / Operator Contact Address
505 West Ultradent Drive (10200 South), --, South Jordan, UT 84095, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K993846
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2007-12-20
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2023-07-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-20
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2014-09-19
EKJ Burnisher, Operative Dental Class 1 872.4565 1995-09-28
EMA Cement, Dental Dental Class 2 872.3275 2012-01-24
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-08-14
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2015-08-25
EMA Cement, Dental Dental Class 2 872.3275 2007-12-20
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-20
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-20
EKM Gutta-Percha Dental Class 1 872.3850 2007-12-19
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-12-20
JES Floss, Dental Dental Class 1 872.6390 2013-01-30
ELW Material, Impression Dental Class 2 872.3660 2016-11-02
LBH Varnish, Cavity Dental Class 2 872.3260 2007-12-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-20
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-20
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2020-05-12
KXR Applicator, Resin Dental Class 1 872.3140 1994-08-16
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 1998-07-20
EMA Cement, Dental Dental Class 2 872.3275 2019-08-28
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2019-08-28
JET Pick, Massaging Dental Class 1 872.6650 2007-07-26
MVL Cord, Retraction Unknown Class U N/A 2007-12-18
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-19
ELW Material, Impression Dental Class 2 872.3660 2012-07-17
KJJ Cleanser, Root Canal Unknown Class U N/A 2007-12-18
LBH Varnish, Cavity Dental Class 2 872.3260 2007-12-20
EMA Cement, Dental Dental Class 2 872.3275 2007-12-19
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2007-12-20
ELW Material, Impression Dental Class 2 872.3660 2007-12-19
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2016-07-14
PEQ Accessories To Examination Light General Hospital Class 1 880.6320 2021-04-01
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2021-04-01
EAQ Detector, Ultraviolet Dental Class 2 872.6350 2021-04-01
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2021-11-18
EMA Cement, Dental Dental Class 2 872.3275 2007-07-26
ELR Post, Root Canal Dental Class 1 872.3810 1996-08-13
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2007-07-26
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2021-11-29
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2021-11-29
MVL Cord, Retraction Unknown Class U N/A 2013-02-07
ELW Material, Impression Dental Class 2 872.3660 2023-01-17
DZN Instruments, Dental Hand Dental Class 1 872.4565 1999-11-03
KJJ Cleanser, Root Canal Unknown Class U N/A 2007-12-19
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2023-04-19
LBH Varnish, Cavity Dental Class 2 872.3260 2014-10-27
EIH Powder, Porcelain Dental Class 2 872.6660 2007-12-18
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2009-06-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2020-11-04
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2017-07-20
ELW Material, Impression Dental Class 2 872.3660 2007-12-19
ELW Material, Impression Dental Class 2 872.3660 2007-12-19
JEP Retainer, Matrix Dental Class 1 872.4565 1999-07-06
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2008-11-07
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2011-11-01
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2007-12-19
LFC Device, Caries Detection Dental Class 2 872.1740 2007-12-18
KJJ Cleanser, Root Canal Unknown Class U N/A 2018-03-05
ELW Material, Impression Dental Class 2 872.3660 2016-11-02
ELW Material, Impression Dental Class 2 872.3660 2016-11-02
EIG Retractor, All Types Dental Class 1 872.4565 2007-12-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2023-08-23
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2023-08-23
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 1994-08-16
EJL Bur, Dental Dental Class 1 872.3240 1994-08-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2007-12-20
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2010-05-12
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-20
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2013-01-30
LBH Varnish, Cavity Dental Class 2 872.3260 2007-12-19
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2011-04-07
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2015-12-09
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 1996-07-03
EHM Strip, Polishing Agent Dental Class 1 872.6010 2007-07-26
EHJ Disk, Abrasive Dental Class 1 872.6010 1995-09-28
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2007-12-20
LBH Varnish, Cavity Dental Class 2 872.3260 2007-12-20
EIG Retractor, All Types Dental Class 1 872.4565 1999-02-03
EIE Dam, Rubber Dental Class 1 872.6300 1995-09-28
EJQ Wheel, Polishing Agent Dental Class 1 872.6010 1999-03-18
PEM Dental Barriers And Sleeves General, Plastic Surgery Class 2 878.4370 2017-12-07
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2009-06-15
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2007-12-19
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-20
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2007-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ULTRADENT PRODUCTS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K941532 Bio-Probe, Inc. BIOCALEX 6/9 1994-08-02
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0011-2020 Inter-Med Llc U
Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020 Inter-Med Llc U
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1718912. Last updated year: 2026. Please use registration number 1718912 when referencing this establishment in official correspondence.
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