FDA-Device2016-10-12Class II

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

Ivoclar Vivadent, Inc.
Hazard

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.

Sold states
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.
Affected count
60 units
Manufactured in
175 Pineview Dr, N/A, Amherst, NY, United States
Products
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0019-2017

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