Device 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
Z-3068-2024
Product summary
- Event
- Event 95175
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2450
- Official record key
device-enforcement:Z-3068-2024
Official wording
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Code information: Lot Code: Model No 4757; UDI-DI 00883205028334; Lot Number C15C2; Expiration Date 31-May-2026
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
Derived failure modes
-
Foreign material or chemical contamination
particulates