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Ultradent Products, Inc. recalls Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Sof
Recalled September 18, 2024 · FDA recall Z-3068-2024 · Ultradent Products
Hazard
Due to a manufacturing issue, red particulates present in the expressed composite. · FDA Class II
Units
2450
Sold at
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
Description
Due to a manufacturing issue, red particulates present in the expressed composite.
Product
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
Manufacturer(s)
Ultradent Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →