FDA-Device2013-09-25Class II
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
Hazard
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
Sold states
Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.
Affected count
197 units
Manufactured in
1717 W Collins Ave, N/A, Orange, CA, United States
Products
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2013Don't want to check this manually?
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