Food, drugs, devices › Ivoclar Vivadent, Inc.

Device recall: Article No. NA6050411, Valiant PhD No. 1 Econo

FDA enforcement event 93796 · Class II · initiated 21 Dec 2023 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordAmherst, NY

FDA enforcement event 93796 is a device recall by Ivoclar Vivadent, Inc. of Amherst, NY, initiated 21 Dec 2023 and classified Class II, with 1 product record.

FDA defines Class II as 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. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Ivoclar Vivadent, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ivoclar Vivadent, Inc., Amherst, NY.

Reason for recall

"Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected."

Distribution

"US Nationwide distribution in the states IN and TN."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1006-2024	Article No. NA6050411, Valiant PhD No. 1 Econo	2 boxes (500 per box)	Class II	Ongoing	14 Feb 2024

Context

88%of 2023 device events are Class II917 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Ivoclar Vivadent, Inc.

Initiated	Product (first record)	Type	Class	Records
3 Aug 2017	Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501	Device	Class III	4
9 Nov 2016	Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Denta	Device	Class II	3
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

All 9 events for Ivoclar Vivadent, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution in the states IN and TN."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.