Recall Register

Ultradent Products, Inc.: FDA recalls

FDA enforcement events from 2012 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Ultradent Products, Inc. as the recalling firm in 15 events. The events have 24 product records. The recalls started from 2012 to 2026. By FDA enforcement events, Ultradent Products, Inc. is number 233 of 1,628 firms that have a page. Events that Ultradent Products, Inc. started: 1 in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class III is 26.7% of its events and 8.6% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

15 events, newest first.

FDA enforcement events of Ultradent Products, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
28 Jan 2026Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.DeviceClass II1Ongoing
2 Aug 2024Brand 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…DeviceClass II3Ongoing
1 Jun 2022Peak 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.DeviceClass II1Completed
31 Aug 2020PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.DeviceClass II1Terminated
12 Jul 2018Enamelast 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…DeviceClass II1Terminated
4 Aug 2017Ultradent 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.DeviceClass II5Terminated
14 Dec 2016NanoTips 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…DeviceClass II1Terminated
17 Nov 2016UltraSeal 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.DeviceClass II1Terminated
22 Dec 2015InterGuard 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.DeviceClass II1Terminated
19 Nov 2013Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.DeviceClass III1Terminated
8 Mar 2013Opalescence Treswhite Supreme Peach Patient KitFoodClass III1Terminated
8 Feb 2013Avex 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.DeviceClass III1Terminated
4 Feb 2013Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.DeviceClass III2Terminated
18 Jun 2012Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.FoodClass II3Terminated
24 May 2012Peak 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…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Ultradent Products, Inc.: events for each product type
TypeEvents
Device13
Food2
Ultradent Products, Inc.: events in each class
ClassEvents
Class II11
Class III4
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Ultradent Products, Inc., by the year that the recall started. The largest year is 2013, with 4 events.

Official channels

Cite this page

Recall Register. Ultradent Products, Inc.: FDA recalls. https://recallregister.com/firm/ultradent-products-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
UT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Ultradent Products, Inc. have?
Class II: 11 events. Class III: 4 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Ultradent Products, Inc. have?
Device: 13 events. Food: 2 events.
What is the newest FDA recall of Ultradent Products, Inc.?
FDA event 98419, which the firm started on 28 Jan 2026. The first product in the record is: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.
How many FDA recalls of Ultradent Products, Inc. have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.