Ivoclar Vivadent, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 21

Known Identifiers & Locations

FEI Numbers 1316092
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (21)

Recall # Product Description Initiation Date Status Action
Z-0017-2017 Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0018-2017 Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0019-2017 Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0020-2017 Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0021-2017 Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0022-2017 Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0023-2017 Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0024-2017 Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0025-2017 Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0026-2017 Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0027-2017 Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0028-2017 Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0029-2017 Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0030-2017 Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0031-2017 Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0032-2017 Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0033-2017 Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0034-2017 Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0035-2017 Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0036-2017 Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details
Z-0037-2017 Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain Reason: 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. 2016-05-27 Terminated View Details

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