FDAAugust 2, 2024device

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ultradent productsultradent

UPCs

00883205106094

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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... — Recall Details · AllClear