Reported Sep 18, 2024 · Ongoing

Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A…

Ultradent Products, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800

Brand NameVit-l-escence
Product NameVit-l-escence
Singles A3 Model/Catalog Number1203-
Software VersionN/A
Product DescriptionVit-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 Shadesfluorescent properties to replicate natural dentin. Available in 18 dentin shades
Enamel Shadesopalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades
ComponentN/A

Lot codes and dates: Lot Code
Model No 1203
UDI-DI 00883205106094
Lot Number C1CF7
Expiration Date 04-Aug-2027
Amount recalled: 90

The agency filed one notice per product. You are reading one of them; the other 2 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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14 in total.