Recall Z-3066-2024— Ultradent Products, Inc.

Name: FDA recall Z-3066-2024
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: K974282. 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 enamel shades including pearl, translucent, and opaque shades. 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

K974282 — VITALESCENCEUltradent Products, Inc.·cleared 1998-01-29

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: 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 enamel shades including pearl, translucent, and opaque shades. 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.