Ivoclar Vivadent, Inc.: FDA recalls

FDA enforcement reports name Ivoclar Vivadent, Inc. as the recalling firm in 9 events. The events have 34 product records. The recalls started from 2013 to 2023. All the events are device recalls.

See the 9 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 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

9 events, newest first.

FDA enforcement events of Ivoclar Vivadent, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
21 Dec 2023	Article No. NA6050411, Valiant PhD No. 1 Econo	Device	Class II	1	Ongoing
3 Aug 2017	Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501	Device	Class III	4	Terminated
9 Nov 2016	Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material	Device	Class II	3	Terminated
11 Jul 2016	OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.	Device	Class II	1	Terminated
27 May 2016	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain	Device	Class II	21	Terminated
12 Feb 2016	Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant	Device	Class II	1	Terminated
9 Jul 2015	IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations	Device	Class II	1	Terminated
14 Apr 2014	bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.	Device	Class II	1	Terminated
23 Sep 2013	ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations	Device	Class II	1	Terminated

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.

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Type and class

Ivoclar Vivadent, Inc.: events for each product type
Type		Events
Device		9

Ivoclar Vivadent, Inc.: events in each class
Class		Events
Class II		8
Class III		1

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: 1

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 Ivoclar Vivadent, Inc., by the year that the recall started. The largest year is 2016, with 4 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Ivoclar Vivadent, Inc.: FDA recalls. https://recallregister.com/firm/ivoclar-vivadent-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: NY

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 compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Ivoclar Vivadent, Inc. have?: Class II: 8 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Ivoclar Vivadent, Inc.?: FDA event 93796, which the firm started on 21 Dec 2023. The first product in the record is: Article No. NA6050411, Valiant PhD No. 1 Econo
How many FDA recalls of Ivoclar Vivadent, Inc. have the status Ongoing?: 1 event has 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.