Recall Z-3068-2024— Ultradent Products, Inc.

Name: FDA recall Z-3068-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-02

Class II · Ongoing

Class II FDA medical device recall by Ultradent Products, Inc., initiated 2024-08-02. It names one FDA 510(k) clearance: K201795. 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. Reason: Due to a manufacturing issue, red particulates present in the expressed composite..

Recalling firm: Ultradent Products, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-02
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K201795 — TranscendUltradent Product, Inc.·cleared 2020-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Due to a manufacturing issue, red particulates present in the expressed composite.

Data sourced from openFDA. This site is unofficial and independent of the FDA.