Device recall: Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Class II FDA enforcement event 74320. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
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 27 May 2016. The firm address in the FDA record is in Amherst, NY. FDA put the recall in Class II. FDA event 74320 has 21 product records. The first FDA enforcement report date is 12 Oct 2016. The record gives the status Terminated, with the termination date 14 Jun 2018.
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 . openFDA export of .
Distribution
In the words of FDA.
US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
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
21 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0017-2017 | Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain | 79 units | Class II | Terminated | 12 Oct 2016 |
| Z-0018-2017 | Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain | 11 units | Class II | Terminated | 12 Oct 2016 |
| Z-0019-2017 | Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain | 60 units | Class II | Terminated | 12 Oct 2016 |
| Z-0020-2017 | Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain | 25 units | Class II | Terminated | 12 Oct 2016 |
| Z-0021-2017 | Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain | 94 units | Class II | Terminated | 12 Oct 2016 |
| Z-0022-2017 | Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain | 72 units | Class II | Terminated | 12 Oct 2016 |
| Z-0023-2017 | Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain | 42 units | Class II | Terminated | 12 Oct 2016 |
| Z-0024-2017 | Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain | 17 units | Class II | Terminated | 12 Oct 2016 |
| Z-0025-2017 | Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain | 11 units | Class II | Terminated | 12 Oct 2016 |
| Z-0026-2017 | Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain | 43 units | Class II | Terminated | 12 Oct 2016 |
| Z-0027-2017 | Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain | 15 units | Class II | Terminated | 12 Oct 2016 |
| Z-0028-2017 | Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain | 27 units | Class II | Terminated | 12 Oct 2016 |
| Z-0029-2017 | Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain | 7 units | Class II | Terminated | 12 Oct 2016 |
| Z-0030-2017 | Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain | 37 units | Class II | Terminated | 12 Oct 2016 |
| Z-0031-2017 | Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain | 19 units | Class II | Terminated | 12 Oct 2016 |
| Z-0032-2017 | Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain | 13 units | Class II | Terminated | 12 Oct 2016 |
| Z-0033-2017 | Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain | 10 units | Class II | Terminated | 12 Oct 2016 |
| Z-0034-2017 | Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain | 40 units | Class II | Terminated | 12 Oct 2016 |
| Z-0035-2017 | Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain | 18 units | Class II | Terminated | 12 Oct 2016 |
| Z-0036-2017 | Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain | 9 units | Class II | Terminated | 12 Oct 2016 |
| Z-0037-2017 | Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain | 5 units | Class II | Terminated | 12 Oct 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
- 21Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
Official channels
- FDA enforcement report Z-0017-2017The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 74320. https://recallregister.com/fda/ii/74320/. Source: openFDA enforcement reports. Data through .
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:
US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
- What quantity of product is in FDA event 74320?
- The event has 21 product records. The first record gives this quantity:
79 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.