Device recall: Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage…

Class II FDA enforcement event 75620. Recall start date: 9 Nov 2016. Status in the FDA record: Terminated. Termination date: 18 Jun 2018.

Reason for recall, in the words of FDA

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Ivoclar Vivadent, Inc. started this device recall on 9 Nov 2016. The firm address in the FDA record is in Amherst, NY. FDA put the recall in Class II. FDA event 75620 has 3 product records. The first FDA enforcement report date is 14 Dec 2016. The record gives the status Terminated, with the termination date 18 Jun 2018.

FDA enforcement report The 3 product records

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.

Worldwide Distribution - US Nationwide and the countries of Canada and Australia

Recalling firm

Ivoclar Vivadent, Inc., Amherst, NY.

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

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

Products

3 product records in the event.

FDA event 75620: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0717-2017	Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material	US: 4659 units, Canada: 729 units	Class II	Terminated	14 Dec 2016
Z-0718-2017	Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material	US: 1867 units, Canada: 465 units	Class II	Terminated	14 Dec 2016
Z-0719-2017	Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material	US: 2090 units, Canada: 331 units, Australia: 465 units	Class II	Terminated	14 Dec 2016

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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2016: 1,232
Share of these events in Class II: 91%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Ivoclar Vivadent, Inc.
Initiated	Product (first record)	Type	Class	Records
21 Dec 2023	Article No. NA6050411, Valiant PhD No. 1 Econo	Device	Class II	1
3 Aug 2017	Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501	Device	Class III	4
11 Jul 2016	OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/P	Device	Class II	1
27 May 2016	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain	Device	Class II	21
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/Pro	Device	Class II	1
9 Jul 2015	IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray use	Device	Class II	1
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	Device	Class II	1
23 Sep 2013	ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations	Device	Class II	1

Ivoclar Vivadent, Inc.: all 9 events

Official channels

FDA enforcement report Z-0717-2017The 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.

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Cite this page

Recall Register. FDA enforcement event 75620. https://recallregister.com/fda/ii/75620/. 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: Worldwide Distribution - US Nationwide and the countries of Canada and Australia
What quantity of product is in FDA event 75620?: The event has 3 product records. The first record gives this quantity: US: 4659 units, Canada: 729 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2016 have the same class?: 91% of the 1,232 device events that started in 2016 are in Class II.