Ultradent Products, Inc.: Device Recall
Recall #Z-3066-2024 · 08/02/2024
Recall Details
- Recall Number
- Z-3066-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ultradent Products, Inc.
- Status
- Ongoing
- Date Initiated
- 08/02/2024
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90
Reason for Recall
Due to a manufacturing issue, red particulates present in the expressed composite.
Product Description
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
Distribution Pattern
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
Other Recalls by Ultradent Products, Inc.
- Class II: Risk 08/02/2024
- Class II: Risk 08/02/2024