Recall Z-3066-2024 ยท EBF Material, Tooth Shade, Resin
Ultradent Products, Inc.
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. Availabl
| Date | Sep 6, 2024 (initiated Aug 2, 2024) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue, red particulates present in the expressed composite. |
| Root cause | Material/Component Contamination |
| Action | On 08/6/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via 3-day delivery to customer informing them that firm has identified a potential presence of red or blue polyvinyl particulate in the composite. Customer are instructed to: -Discard all remaining Transcend Singles or Vit-lescence Singles from lots listed in the Recall Letter. -Fill out Customer Response Form and return to Ultradent indicating disposal of product. -For any concerns or questions related to your replacement product or product use, contact Ultradent Customer Service at 1-888-230-1420. -Should you experien |
| Quantity | 90 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974282 | VITALESCENCE Ultradent Products, Inc., Jan 29, 1998 |