Vit-l-escence Singles (Ultradent) – Manufacturing Particulate Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 en
Brand
Ultradent Products, Inc.
Lot Codes / Batch Numbers
Lot Code: Model No 1203, UDI-DI 00883205106094, Lot Number C1CF7, Expiration Date 04-Aug-2027
Products Sold
Lot Code: Model No 1203; UDI-DI 00883205106094; Lot Number C1CF7; Expiration Date 04-Aug-2027
Ultradent Products, Inc. is recalling Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Softwar due to Due to a manufacturing issue, red particulates present in the expressed composite.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a manufacturing issue, red particulates present in the expressed composite.
Recommended Action
Per FDA guidance
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 experience any adverse reactions or quality problems with the use of this product, these can also be reported to the FDA s MedWatch Adverse Event Reporting program with online, by regular mail or by fax. o Complete and submit the report online o Regular mail or fax: download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, SC, TN, TX, UT, VT, VA, WV, WI
Page updated: Jan 10, 2026