FDAFDA · Food and drugs·Recall number Z-3066-2024
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
Published September 18, 2024 · Recall initiated: August 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a manufacturing issue, red particulates present in the expressed composite.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultradent Products, Inc.
- Distributor
- 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
- Lot
- Lot Code: Model No 1203; UDI-DI 00883205106094; Lot Number C1CF7; Expiration Date 04-Aug-2027
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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