Ultradent Products Inc.
South Jordan, UT, US
Ultradent Products Inc. appears in FDA device records in South Jordan, UT. FDA records list 104 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 104FDA records hold 104 510(k) clearances for Ultradent Products Inc. between 1992 and 2026. The busiest year on record is 1995, with 11. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 8 |
| 1993 | 7 |
| 1994 | 6 |
| 1995 | 11 |
| 1996 | 3 |
| 1997 | 9 |
| 1998 | 7 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 4 |
| 2011 | 5 |
| 2013 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 3 |
| 2022 | 2 |
| 2024 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | EBF | Substantially Equivalent | |
| K261404 | UltraEZ | LBH | Substantially Equivalent | |
| K240743 | Peak Universal Bond | KLE | Substantially Equivalent | |
| K240694 | FORMA Composite (Shade A3D) | EBF | Substantially Equivalent | |
| K221909 | J-Temp | EBF | Substantially Equivalent | |
| K220471 | VALO X, VALO X Accessory Lenses | EBZ | Substantially Equivalent | |
| K211905 | UltraCal XS | KIF | Substantially Equivalent | |
| K211237 | UltraTemp Rez II | EMA | Substantially Equivalent | |
| K210550 | VALO Grand Corded and Accessory Lenses | EBZ | Substantially Equivalent | |
| K190627 | VALO Grand Corded | EBZ | Substantially Equivalent | |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | KJJ | Substantially Equivalent | |
| K160551 | VALO Grand | EBZ | Substantially Equivalent | |
| K152064 | Astringedent Clear | MVL | Substantially Equivalent | |
| K151094 | Mosaic Universal Composite | EBF | Substantially Equivalent | |
| K131357 | PEAK Z | KLE | Substantially Equivalent | |
| K123215 | VISCOSTAT CLEAR | MVL | Substantially Equivalent | |
| K112517 | ULTRASEAL XT HYDRO | EBC | Substantially Equivalent | |
| K111836 | PERMASHADE VENEER CEMENT | EMA | Substantially Equivalent | |
| K111696 | OPAL BAND CEMENT | DYH | Substantially Equivalent | |
| K111017 | CLEARTEMP | EMA | Substantially Equivalent | |
| K110582 | VALO CORDLESS | EBZ | Substantially Equivalent | |
| K101245 | ULTRASEAL ID | EBC | Substantially Equivalent | |
| K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | KLE | Substantially Equivalent | |
| K100301 | OPAL BOND FLOW | DYH | Substantially Equivalent | |
| K094006 | OPAL BOND MV | DYH | Substantially Equivalent | |
| K090355 | OPAL SEAL | DYH | Substantially Equivalent | |
| K083647 | VALO, MODEL 5919 | EBZ | Substantially Equivalent | |
| K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET | EMA | Substantially Equivalent | |
| K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | LBH | Substantially Equivalent | |
| K061438 | ULTRAEZ DESENSITIZING GEL | LBH | Substantially Equivalent | |
| K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | KIF | Substantially Equivalent | |
| K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | DYW | Substantially Equivalent | |
| K063703 | CITRIC ACID 20% SOLUTION, MODEL 329 | KJJ | Substantially Equivalent | |
| K063558 | PEAK SE, MODEL 5135 | KLE | Substantially Equivalent | |
| K063557 | PEAK BOND, MODEL 5133 | KLE | Substantially Equivalent | |
| K060335 | FILE-EZE | KJJ | Substantially Equivalent | |
| K060334 | GI DENTSTAT | EMA | Substantially Equivalent | |
| K051750 | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 | LBH | Substantially Equivalent | |
| K042583 | CALC-I-OSS | LYC | Substantially Equivalent | |
| K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM | DYW | Substantially Equivalent | |
| K043119 | AMELOGEN PLUS | EBF | Substantially Equivalent | |
| K042756 | ENDOREZ | KIF | Substantially Equivalent | |
| K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM | DYW | Substantially Equivalent | |
| K032626 | PERMAQUICK SE BONDING SYSTEM | KLE | Substantially Equivalent | |
| K032627 | ULTRADENT CITRIC ACID 10% SOLUTION | KJJ | Substantially Equivalent | |
| K023042 | PQ1 | KLE | Substantially Equivalent | |
| K010070 | ULTRAPAK NEHA | MVL | Substantially Equivalent | |
| K003383 | PALMLIGHT | EBZ | Substantially Equivalent | |
| K000189 | PQ1 | KLE | Substantially Equivalent | |
| K993846 | ULTRASEAL XT PLUS | EBC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1718912 | 1718912 | Ultradent Products Inc. | 505 W Ultradent Dr (10200 South), South Jordan, UT 84095 US | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PEQAccessories To Examination Light
- LYUAccessory, Surgical Apparel
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- KOJAirbrush
- KXRApplicator, Resin
- LYCBone Grafting Material, Synthetic
- DYWBracket, Plastic, Orthodontic
- EJLBur, Dental
- EKJBurnisher, Operative
- EMACement, Dental
- KJJCleanser, Root Canal
- MVLCord, Retraction
- EBGCrown And Bridge, Temporary, Resin
- EHKCup, Prophylaxis
- EIEDam, Rubber
- PEMDental Barriers And Sleeves
- EAQDetector, Ultraviolet
- LFCDevice, Caries Detection
- EHJDisk, Abrasive
- EHZEvacuator, Oral Cavity
- JESFloss, Dental
- EKMGutta-Percha
- EJBHandle, Instrument, Dental
- EFBHandpiece, Air-Powered, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- EIYInstrument, Filling, Plastic, Dental
- DZNInstruments, Dental Hand
- EJKLiner, Cavity, Calcium Hydroxide
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- JETPick, Massaging
- ELRPost, Root Canal
- EIHPowder, Porcelain
- KIFResin, Root Canal Filling
- JEPRetainer, Matrix
- EIGRetractor, All Types
- ELCScaler, Ultrasonic
- EBCSealant, Pit And Fissure, And Conditioner
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- EHMStrip, Polishing Agent
- EJISyringe, Cartridge
- EICSyringe, Periodontic, Endodontic, Irrigating
- EIDSyringe, Restorative And Impression Material
- EFSUnit, Oral Irrigation
- LBHVarnish, Cavity
- EGDWax, Dental, Intraoral
- EJQWheel, Polishing Agent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1689-2026 | Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. | Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. | Class II | Open, Classified | |
| Z-3068-2024 | Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Open, Classified | |
| Z-3067-2024 | Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Open, Classified | |
| Z-3066-2024 | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Open, Classified | |
| Z-1368-2022 | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures. | SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer. | Class II | Completed | |
| Z-0053-2021 | PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper limit particle distribution. | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. | Class II | Terminated | |
| Z-0690-2019 | Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity. | Dental varnish has the possibility of having an unpleasant and off flavor. | Class II | Terminated | |
| Z-3218-2017 | Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Terminated | |
| Z-3217-2017 | Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Terminated | |
| Z-3216-2017 | Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Terminated | |
| Z-3215-2017 | Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Terminated | |
| Z-3214-2017 | Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. | Class II | Terminated | |
| Z-1034-2017 | NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT plus, UltraSeal XT hydro, Ultra-Etch, PermaFloIdeal for microscopic restorative dentistry | Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe. | Class II | Terminated | |
| Z-0704-2017 | UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations. | There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T. | Class II | Terminated | |
| Z-0583-2016 | InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion. | Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed. | Class II | Terminated | |
| Z-0481-2014 | Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment. | Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution. | Class III | Terminated | |
| Z-0876-2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets. | Orthodontic brackets distributed was incorrectly labeled. | Class III | Terminated | |
| Z-0812-2013 | Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics. | Incorrect packaging of regular set and fast set cartridges. | Class III | Terminated | |
| Z-0811-2013 | Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. | Incorrect packaging of regular set and fast set cartridges. | Class III | Terminated | |
| Z-1822-2012 | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite. | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain