Recall Z-0018-2017— Ivoclar Vivadent, Inc.

Name: FDA recall Z-0018-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-27

Class II · Terminated

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2016-05-27, terminated 2018-06-14. It names one FDA 510(k) clearance: K152118. Product: 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..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-27
Terminated: 2018-06-14
Firm location: Amherst, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K152118 — Zenostar MT, Zenostar Color LiquidsWieland Dental + Technik GmbH & Co. KG·cleared 2015-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.