Device recall: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use…

Class III FDA enforcement event 66978. Recall start date: 19 Nov 2013. Status in the FDA record: Terminated. Termination date: 6 Oct 2014.

Reason for recall, in the words of FDA

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, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Ultradent Products, Inc. started this device recall on 19 Nov 2013. The firm address in the FDA record is in South Jordan, UT. FDA put the recall in Class III. FDA event 66978 has 1 product record. The first FDA enforcement report date is 18 Dec 2013. The record gives the status Terminated, with the termination date 6 Oct 2014.

FDA enforcement report The 1 product record

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution including UT, CA, WA, VA, OH, and TN.

Recalling firm

Ultradent Products, Inc., South Jordan, UT.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 66978: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0481-2014	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.	217 units	Class III	Terminated	18 Dec 2013

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class III: The lowest of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class III: 5%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Ultradent Products, Inc.
Initiated	Product (first record)	Type	Class	Records
28 Jan 2026	Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.	Device	Class II	1
2 Aug 2024	Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Produ	Device	Class II	3
1 Jun 2022	Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime	Device	Class II	1
31 Aug 2020	PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flow	Device	Class II	1
12 Jul 2018	Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit	Device	Class II	1
4 Aug 2017	Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used	Device	Class II	5
14 Dec 2016	NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless	Device	Class II	1
17 Nov 2016	UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus i	Device	Class II	1
22 Dec 2015	InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard	Device	Class II	1
8 Mar 2013	Opalescence Treswhite Supreme Peach Patient Kit	Food	Class III	1

Ultradent Products, Inc.: all 15 events

Official channels

FDA enforcement report Z-0481-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 66978. https://recallregister.com/fda/iii/66978/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
What quantity of product is in FDA event 66978?: The FDA record gives this quantity: 217 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 5% of the 1,236 device events that started in 2013 are in Class III.