Data / Medical devices / United States / Ultradent Products Inc.
Ultradent Products Inc.: FDA-registered device maker in South Jordan, UT, United States, 78 510(k) clearances
Ultradent Products Inc. is registered with the FDA (registration 1718912) in South Jordan, UT, United States. It lists 48 device types. The FDA files 78 510(k) clearances under its listings, the newest dated July 1, 2026. 13 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1718912
- Address
- 505 W Ultradent Dr (10200 South), South Jordan, UT, United States, 84095
- Owner or operator
- ULTRADENT PRODUCTS, INC. (1718962)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- August 16, 1994
- Registered through
- 2027
- Brand names listed
- 1.2 mL Plastic Syringe, 3 mL Impression Syringe, 5 mL Plastic Syringe, Amelogen Plus, Black Micro FX Tips, Black Micro Tips, Black Mini Brush Tips, Black Mini Tips and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2026 | K262228 | Transcend Bulk Fill Flowable Composite | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 30, 2026 | K261404 | UltraEZ | LBH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 15, 2024 | K240694 | FORMA Composite (Shade A3D) | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| August 18, 2023 | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | EBC | Substantially Equivalent | Ultradent Product, Inc. | accessdata.fda.gov |
| July 1, 2022 | K221909 | J-Temp | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 22, 2022 | K220471 | VALO X, VALO X Accessory Lenses | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 17, 2021 | K211531 | Cordless Prophy System, Model: i-Polish | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| October 13, 2021 | K211905 | UltraCal XS | KIF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 13, 2021 | K211237 | UltraTemp Rez II | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 1, 2021 | K210550 | VALO Grand Corded and Accessory Lenses | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 28, 2020 | K201795 | Transcend | EBF | Substantially Equivalent | Ultradent Product, Inc. | accessdata.fda.gov |
| April 29, 2019 | K190627 | VALO Grand Corded | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 11, 2019 | K181917 | MTA2.3 MATERIALS | KIF | Substantially Equivalent | NuSmile, Ltd. | accessdata.fda.gov |
| February 9, 2018 | K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | KJJ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 1, 2016 | K161239 | MTA2.2 MATERIAL | KIF | Substantially Equivalent | Avalon Biomed, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160551 | VALO Grand | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 3, 2016 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | PEM | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| July 21, 2015 | K151094 | Mosaic Universal Composite | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 18, 2014 | K132953 | TIDISHEILD | PEM | Substantially Equivalent | Tidi Products,Llc | accessdata.fda.gov |
| November 1, 2013 | K132109 | ENAMELAST | LBH | Substantially Equivalent | Ultradent Products Inc. / Oratech, LLC | accessdata.fda.gov |
| October 24, 2013 | K132255 | ULTRACEM | EMA | Substantially Equivalent | Ultradent Products Inc. / Oratech, LLC | accessdata.fda.gov |
| September 6, 2013 | K131357 | PEAK Z | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 5, 2013 | K123215 | VISCOSTAT CLEAR | MVL | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 27, 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B | EBG | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| December 11, 2012 | K122892 | MTA2 ROOT AND PULP MATERIALS | KIF | Substantially Equivalent | Avalon Biomed, Inc. | accessdata.fda.gov |
| September 23, 2011 | K112517 | ULTRASEAL XT HYDRO | EBC | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 16, 2011 | K111836 | PERMASHADE VENEER CEMENT | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 7, 2011 | K111696 | OPAL BAND CEMENT | DYH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| June 6, 2011 | K111017 | CLEARTEMP | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110582 | VALO CORDLESS | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 8, 2010 | K102739 | HYDROCOLOR 5 | ELW | Substantially Equivalent | Cascades Device Consulting Associates | accessdata.fda.gov |
| July 16, 2010 | K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 29, 2010 | K100301 | OPAL BOND FLOW | DYH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 23, 2010 | K094006 | OPAL BOND MV | DYH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 29, 2009 | K090355 | OPAL SEAL | DYH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 23, 2009 | K083647 | VALO, MODEL 5919 | EBZ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 9, 2009 | K083701 | PANASIL INITIAL CONTACT AND PANASIL TRAY | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| September 8, 2008 | K082560 | PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| August 6, 2008 | K082157 | KETTOSIL AND SILGINAT | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| May 1, 2008 | K081120 | FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS | ELW | Substantially Equivalent | Kettenbach GmbH & Co. KG | accessdata.fda.gov |
| June 12, 2007 | K061438 | ULTRAEZ DESENSITIZING GEL | LBH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| May 8, 2007 | K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 | KIF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| May 3, 2007 | K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 | DYW | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 25, 2007 | K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC | EFB | Substantially Equivalent | Osseo Scientific, LLC | accessdata.fda.gov |
| December 21, 2006 | K063703 | CITRIC ACID 20% SOLUTION, MODEL 329 | KJJ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 14, 2006 | K063558 | PEAK SE, MODEL 5135 | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 24, 2006 | K060335 | FILE-EZE | KJJ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 20, 2005 | K050895 | SURPASSON P5 NEWTRON | ELC | Substantially Equivalent | Satelec | accessdata.fda.gov |
| January 24, 2005 | K043118 | HYDROGUM SOFT | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| December 17, 2004 | K043119 | AMELOGEN PLUS | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 18, 2002 | K024034 | OCCLUFAST ROCK | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| October 28, 2002 | K023042 | PQ1 | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 16, 2000 | K993846 | ULTRASEAL XT PLUS | EBC | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 2, 2000 | K994261 | ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 31, 1998 | K981596 | ULTRAPAK E | MVL | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 2, 1998 | K974413 | PERMAFLO | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| January 29, 1998 | K974282 | VITALESCENCE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| August 1, 1997 | K972239 | ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| July 16, 1997 | K972027 | ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) | ELW | Substantially Equivalent | Zhermack S.P.A. | accessdata.fda.gov |
| June 3, 1997 | K971284 | OPALDAM | EIG | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 2, 1997 | K970113 | ULTRA-BLEND PLUS | EJK | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| February 26, 1997 | K964808 | SPETEMP | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| December 12, 1996 | K963979 | ULTRADENT UNIVERSAL DENTIN SEALANT | LBH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 18, 1996 | K960696 | PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM | KLE | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 5, 1995 | K953526 | SEEK | LFC | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| May 10, 1995 | K951582 | ULTRADENT PORCELAIN ETCH | EIH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| March 23, 1995 | K950859 | PERMASEAL | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| June 16, 1994 | K941065 | DEOX, OXYGEN BARRIER VISCOUS SOLUTION | EMA | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| May 27, 1994 | K940860 | CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS | ELW | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| April 13, 1994 | K934415 | FILE-EZE | KJJ | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 9, 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 22, 1993 | K931868 | PRIMADRY PRODUCT LINE | EBC | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 22, 1993 | K925375 | CONSEPSIS SCRUB | LBH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| July 8, 1993 | K924982 | CONSEPSIS(TM) | LBH | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 9, 1992 | K921409 | ENAMEL AND PORCELAIN ETCH PRODUCT LINE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| September 9, 1992 | K921407 | COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE | EBF | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| June 16, 1992 | K921601 | ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE | JES | Substantially Equivalent | Ultradent Products, Inc. | accessdata.fda.gov |
| October 4, 1991 | K913537 | MEMOSIL C.D. | ELW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | 98419 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 2, 2024 | 95175 | Class II | Ongoing | 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 re | Due to a manufacturing issue, red particulates present in the expressed composite. | accessdata.fda.gov |
| June 1, 2022 | 90434 | Class II | Completed | 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 | 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. | accessdata.fda.gov |
| August 31, 2020 | 86432 | Class II | Terminated | 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 distrib | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. | accessdata.fda.gov |
| July 12, 2018 | 81407 | Class II | Terminated | 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 | Dental varnish has the possibility of having an unpleasant and off flavor. | accessdata.fda.gov |
| August 4, 2017 | 77891 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 14, 2016 | 76039 | Class II | Terminated | 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 polypro | 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. | accessdata.fda.gov |
| November 17, 2016 | 75796 | Class II | Terminated | 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 i | 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. | accessdata.fda.gov |
| December 22, 2015 | 72814 | Class II | Terminated | 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 p | 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. | accessdata.fda.gov |
| November 19, 2013 | 66978 | Class III | Terminated | 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. | accessdata.fda.gov |
| February 8, 2013 | 64303 | Class III | Terminated | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #, 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 i | Orthodontic brackets distributed was incorrectly labeled. | accessdata.fda.gov |
| February 4, 2013 | 64272 | Class III | Terminated | 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. | accessdata.fda.gov |
| May 24, 2012 | 62120 | Class II | Terminated | 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 identif | 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. | accessdata.fda.gov |
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Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.