Company ยท US
Ultradent Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2026. Name variants (Inc, Corp, punctuation) are merged.
104510(k) clearances (2 in 12 months)
20recalls (1 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 21 |
| KLE | Agent, Tooth Bonding, Resin | 21 |
| LBH | Varnish, Cavity | 10 |
| EMA | Cement, Dental | 9 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 8 |
| EBZ | Activator, Ultraviolet, For Polymerization | 7 |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 |
| EKN | Point, Paper, Endodontic | 5 |
| KIF | Resin, Root Canal Filling | 5 |
| KJJ | Cleanser, Root Canal | 5 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 |
| MVL | Cord, Retraction | 4 |
| DYW | Bracket, Plastic, Orthodontic | 3 |
| ELW | Material, Impression | 3 |
| DZN | Instruments, Dental Hand | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EFS | Unit, Oral Irrigation | 1 |
| EHJ | Disk, Abrasive | 1 |
| EID | Syringe, Restorative And Impression Material | 1 |
| EIG | Retractor, All Types | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2026 | K262228 | Transcend Bulk Fill Flowable Composite Ultradent Products, Inc. | EBF |
| Apr 30, 2026 | K261404 | UltraEZ Ultradent Products, Inc. | LBH |
| Mar 20, 2024 | K240743 | Peak Universal Bond Ultradent Products, Inc. | KLE |
| Mar 15, 2024 | K240694 | FORMA Composite (Shade A3D) Ultradent Products, Inc. | EBF |
| Jul 1, 2022 | K221909 | J-Temp Ultradent Products, Inc. | EBF |
| Feb 22, 2022 | K220471 | VALO X, VALO X Accessory Lenses Ultradent Products, Inc. | EBZ |
| Oct 13, 2021 | K211905 | UltraCal XS Ultradent Products, Inc. | KIF |
| Jul 13, 2021 | K211237 | UltraTemp Rez II Ultradent Products, Inc. | EMA |
| Mar 1, 2021 | K210550 | VALO Grand Corded and Accessory Lenses Ultradent Products, Inc. | EBZ |
| Apr 29, 2019 | K190627 | VALO Grand Corded Ultradent Products, Inc. | EBZ |
| Feb 9, 2018 | K173163 | ChlorCid, ChlorCid V, ChlorCid Surf Ultradent Products, Inc. | KJJ |
| Jul 13, 2016 | K160551 | VALO Grand Ultradent Products, Inc. | EBZ |
| Sep 24, 2015 | K152064 | Astringedent Clear Ultradent Products, Inc. | MVL |
| Jul 21, 2015 | K151094 | Mosaic Universal Composite Ultradent Products, Inc. | EBF |
| Sep 6, 2013 | K131357 | PEAK Z Ultradent Products, Inc. | KLE |
| Feb 5, 2013 | K123215 | VISCOSTAT CLEAR Ultradent Products, Inc. | MVL |
| Sep 23, 2011 | K112517 | ULTRASEAL XT HYDRO Ultradent Products, Inc. | EBC |
| Sep 16, 2011 | K111836 | PERMASHADE VENEER CEMENT Ultradent Products, Inc. | EMA |
| Sep 7, 2011 | K111696 | OPAL BAND CEMENT Ultradent Products, Inc. | DYH |
| Jun 6, 2011 | K111017 | CLEARTEMP Ultradent Products, Inc. | EMA |
| Apr 28, 2011 | K110582 | VALO CORDLESS Ultradent Products, Inc. | EBZ |
| Sep 17, 2010 | K101245 | ULTRASEAL ID Ultradent Products, Inc. | EBC |
| Jul 16, 2010 | K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) Ultradent Products, Inc. | KLE |
| Apr 29, 2010 | K100301 | OPAL BOND FLOW Ultradent Products, Inc. | DYH |
| Mar 23, 2010 | K094006 | OPAL BOND MV Ultradent Products, Inc. | DYH |
| Apr 29, 2009 | K090355 | OPAL SEAL Ultradent Products, Inc. | DYH |
| Jan 23, 2009 | K083647 | VALO, MODEL 5919 Ultradent Products, Inc. | EBZ |
| Apr 11, 2008 | K080768 | ULTRATEMP FIRM, FAST AND REGULAR SET Ultradent Products, Inc. | EMA |
| Feb 8, 2008 | K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 Ultradent Products, Inc. | LBH |
| Jun 12, 2007 | K061438 | ULTRAEZ DESENSITIZING GEL Ultradent Products, Inc. | LBH |
| May 8, 2007 | K071106 | ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 Ultradent Products, Inc. | KIF |
| May 3, 2007 | K071055 | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 Ultradent Products, Inc. | DYW |
| Dec 21, 2006 | K063703 | CITRIC ACID 20% SOLUTION, MODEL 329 Ultradent Products, Inc. | KJJ |
| Dec 14, 2006 | K063558 | PEAK SE, MODEL 5135 Ultradent Products, Inc. | KLE |
| Dec 12, 2006 | K063557 | PEAK BOND, MODEL 5133 Ultradent Products, Inc. | KLE |
| Feb 24, 2006 | K060335 | FILE-EZE Ultradent Products, Inc. | KJJ |
| Feb 23, 2006 | K060334 | GI DENTSTAT Ultradent Products, Inc. | EMA |
| Sep 19, 2005 | K051750 | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 Ultradent Products, Inc. | LBH |
| Jul 19, 2005 | K042583 | CALC-I-OSS Ultradent Products, Inc. | LYC |
| Mar 31, 2005 | K050730 | MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. | DYW |
| Dec 17, 2004 | K043119 | AMELOGEN PLUS Ultradent Products, Inc. | EBF |
| Oct 26, 2004 | K042756 | ENDOREZ Ultradent Products, Inc. | KIF |
| Feb 26, 2004 | K032625 | ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. | DYW |
| Dec 3, 2003 | K032626 | PERMAQUICK SE BONDING SYSTEM Ultradent Products, Inc. | KLE |
| Nov 12, 2003 | K032627 | ULTRADENT CITRIC ACID 10% SOLUTION Ultradent Products, Inc. | KJJ |
| Oct 28, 2002 | K023042 | PQ1 Ultradent Products, Inc. | KLE |
| Mar 15, 2001 | K010070 | ULTRAPAK NEHA Ultradent Products, Inc. | MVL |
| Feb 6, 2001 | K003383 | PALMLIGHT Ultradent Products, Inc. | EBZ |
| May 11, 2000 | K000189 | PQ1 Ultradent Products, Inc. | KLE |
| Feb 16, 2000 | K993846 | ULTRASEAL XT PLUS Ultradent Products, Inc. | EBC |
Newest 50 of 104.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Ultradent Products, Inc. Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. Open, Classified |
EHJ | None listed |
| Sep 6, 2024 | Ultradent Products, Inc. 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-cu Open, Classified |
EBF | K201795 |
| Sep 6, 2024 | Ultradent Products, Inc. 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 shad Open, Classified |
EBF | K201795 |
| Sep 6, 2024 | Ultradent Products, Inc. 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 e Open, Classified |
EBF | K974282 |
| Jun 1, 2022 | Ultradent Products, Inc. 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 i Completed |
KLE | K063558 |
| Aug 31, 2020 | Ultradent Products, Inc. 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 li Terminated |
EBF | K974413 |
| Jul 12, 2018 | Ultradent Products, Inc. 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
Terminated |
LBH | K132109 |
| Aug 4, 2017 | Ultradent Products, Inc. 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 obt Terminated |
EKN | None listed |
| Aug 4, 2017 | Ultradent Products, Inc. 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 obtu Terminated |
EKN | None listed |
| Aug 4, 2017 | Ultradent Products, Inc. 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 obt Terminated |
EKN | None listed |
| Aug 4, 2017 | Ultradent Products, Inc. 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 obt Terminated |
EKN | None listed |
| Aug 4, 2017 | Ultradent Products, Inc. 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 obtu Terminated |
EKN | None listed |
| Jan 17, 2017 | Ultradent Products, Inc. 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 Terminated |
EID | None listed |
| Dec 3, 2016 | Ultradent Products, Inc. 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 Terminated |
EBC | K993846 |
| Dec 22, 2015 | Ultradent Products, Inc. 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 Terminated |
DZN | None listed |
| Dec 11, 2013 | Ultradent Products, Inc. Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets
Avex CX2 ceramic brackets are intended for use in orthodontic treatment. Terminated |
NJM | None listed |
| Feb 22, 2013 | Ultradent Products, Inc. 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 mechan Terminated |
EJF | K922499 |
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics. Terminated |
ELW | K972027 |
| Feb 13, 2013 | Ultradent Products, Inc. Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics. Terminated |
ELW | K972027 |
| Jun 18, 2012 | Ultradent Products, Inc. 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 plas Terminated |
KLE | K063558 |