FDA-Device2024-09-18Class II
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available
Ultradent Products, Inc.
Hazard
Due to a manufacturing issue, red particulates present in the expressed composite.
Sold states
US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV Foreign: NL, DE, CH, CZ, FR, ES
Affected count
90
Manufactured in
505 W 10200 S, South Jordan, UT, United States
Products
Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 ¿m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3066-2024Don't want to check this manually?
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