Ivoclar Vivadent, Inc.: 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.

Agency Publication Date: October 4, 2016

Affected Products

Product: Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain

Lot No: U54839, expiration date: Jan 25 2018; Lot No: U51735, expiration date: Nov 11 2017; Lot No: U49940, expiration date: Nov 2 2017; Lot No: U44391, expiration date: Oct 19 2017 and Lot No: U39253, expiration date: Sep 20 2017

Product: Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

Lot No: U44405, expiration date: Oct 19 2017; U39262, expiration date: Sep 20 2017

Product: Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

Lot No: U52159, exp date: Mar 30 2018; U52107, exp date: Nov 16 2017; U44397, exp date: Oct 19 2017; and U39255, exp date: Sep 20 2017

Product: Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

Lot No: U49960, Exp. date: Nov 2 2017; U44396, exp. date: Oct 19 2017; and U38897, exp date: Sep 16 2017

Product: Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Lot No: U51483, exp date: Nov 10 2017; U43963, exp date: Nov 2 2017; U43927, exp. date: Nov 2 2017; and U38867, exp date: Sep 16 2017

Product: Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

Lot No: U51512, exp date: Nov 10 2017; U44051, exp date: Oct 19 2017; U43988, exp date: Nov 2 2017; U43931, exp date: Nov 2 2017; and U39054 exp date: Sep 17 2017

Product: Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain

Lot No: U49683, exp date: Nov 2 2017; U49656, exp date: Nov 2 2017; and U39116, exp date: Sep 17 2017

Product: Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain

Lot No: U49659, exp date: Nov 2 2017; U43928, exp date: Oct 19 2017; and U38672, exp date: Sep 15 2017

Product: Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain

Lot No: U38746, exp date: Sep 15 2017

Product: Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain

Lot No: U49851, exp date: Nov 2 2017; U49838, exp date: Nov 2 2017; and U39117, Sep 17 2017

Product: Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain

Lot No: U39398, exp date: Sep 21 2017

Product: Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

Lot No: U38751, exp date: Sep 15 2017

Product: Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain

Lot No: U38887, exp date: Sep 16 2017

Product: Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain

Lot No: U51611, exp date: Nov 11 2017; U50758, exp date: Nov 5 2017; U43929, exp date: Nov 5 2017; and U38834, exp date: Sep 16 2017

Product: Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

Lot No: U44095, exp date: Oct 19 2017 and U38600, exp date: Sep 15 2017

Product: Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain

Lot No: U38627, exp date: Sep 15 2017

Product: Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain

Lot No: U38677, exp date: Sep 15 2017

Product: Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

Lot No: U43930, exp date: Nov 2 2017 and U39238, exp date: Sep 20 2017

Product: Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

Lot No: U38639, exp date: Sep 15 2017

Product: Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain

Lot No: U38680, exp date: Sep 15 2017

Product: Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

Lot No: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74320

Status: Resolved

Manufacturer: Ivoclar Vivadent, Inc.

Manufactured In: United States

Units Affected: 21 products (79 units; 11 units; 60 units; 25 units; 94 units; 72 units; 42 units; 17 units; 11 units; 43 units; 15 units; 27 units; 7 units; 37 units; 19 units; 13 units; 10 units; 40 units; 18 units; 9 units; 5 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products