Ultradent Products, Inc.

FDA recalling firm · 15 enforcement events · 24 product records · 2012–2026 · UT

Ultradent Products, Inc. has 15 FDA enforcement events on this register (24 product records) between 2012 and 2026: 13 device and 2 food; the busiest year was 2013 with 4.

0% of its events are Class I; the most common class is Class II (11). 2 events are listed as ongoing; the recalling firm's address is in UT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
28 Jan 2026	Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.	Device	Class II	1	Ongoing
2 Aug 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…	Device	Class II	3	Ongoing
1 Jun 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.	Device	Class II	1	Completed
31 Aug 2020	PermaFlo 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.	Device	Class II	1	Terminated
12 Jul 2018	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…	Device	Class II	1	Terminated
4 Aug 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.	Device	Class II	5	Terminated
14 Dec 2016	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…	Device	Class II	1	Terminated
17 Nov 2016	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.	Device	Class II	1	Terminated
22 Dec 2015	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.	Device	Class II	1	Terminated
19 Nov 2013	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.	Device	Class III	1	Terminated
8 Mar 2013	Opalescence Treswhite Supreme Peach Patient Kit	Food	Class III	1	Terminated
8 Feb 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.	Device	Class III	1	Terminated
4 Feb 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.	Device	Class III	2	Terminated
18 Jun 2012	Cinnamon 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.	Food	Class II	3	Terminated
24 May 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…	Device	Class II	1	Terminated

By type and class

Device13

Food2

Class II11

Class III4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Ultradent Products, Inc. by year initiated.

Questions and answers

How many FDA recalls has Ultradent Products, Inc. had?

15 enforcement events (24 product records) on this register, 2012–2026: 13 device, 2 food.

Are any Ultradent Products, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Ultradent Products, Inc. recalls?

11 Class II, 4 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.