Ultradent Recalls Vit-l-escence Composite Due to Red Particulates
Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (red particulates) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Ultradent Products, Inc. is recalling Vit-l-escence Singles A3, a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. The recall is due to a manufacturing issue that caused red particulates to be present in the expressed composite.
The affected product is identified by Model Number 1203, UDI-DI 00883205106094, Lot Number C1CF7, and an expiration date of 04-Aug-2027. The recall involves 90 units distributed across various US states and foreign countries, including the Netherlands, Germany, Switzerland, Czech Republic, France, and Spain.
Dental professionals and consumers should stop using the affected product and contact Ultradent Products, Inc. for further instructions or a refund.
The recalled product
- 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%…
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Code: Model No 1203
- UDI-DI 00883205106094
- Lot Number C1CF7
- Expiration Date 04-Aug-2027
Distribution
Part of a larger recall action
This product is one of 3 recalled by Ultradent Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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