Food, drugs, devices › Ivoclar Vivadent, Inc.

Device recall: Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

FDA enforcement event 79064 · Class III · initiated 3 Aug 2017 · status Terminated · terminated 28 Aug 2018

DeviceVoluntary: Firm initiated4 product recordsAmherst, NY

FDA enforcement event 79064 is a device recall by Ivoclar Vivadent, Inc. of Amherst, NY, initiated 3 Aug 2017 and classified Class III, with 4 product records.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 28 Aug 2018. 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

"Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring."

Distribution

"US and Canada"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0665-2018	Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501	2,153 units	Class III	Terminated	28 Feb 2018
Z-0666-2018	Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502	3,255 units	Class III	Terminated	28 Feb 2018
Z-0667-2018	Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503	1,244 units	Class III	Terminated	28 Feb 2018
Z-0668-2018	Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559	2 units	Class III	Terminated	28 Feb 2018

Context

4%of 2017 device events are Class III1,091 events that year

4product records 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
21 Dec 2023	Article No. NA6050411, Valiant PhD No. 1 Econo	Device	Class II	1
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: "Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US and Canada"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Aug 2018. "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.