3M ESPE Imprint II and Paradigm Impression Materials Recalled for Quality Issues
3M is recalling specific lots of Imprint II and Paradigm dental impression materials because a defect reduces moisture displacement, potentially affecting impression quality.
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, but the source text indicates the defect impacts the quality of the impression rather than causing direct patient injury or illness, aligning with moderate severity criteria for functional defects without reported harm.
Plain-English summary
3M Company - Health Care Business is recalling specific lots of 3M ESPE Imprint II Regular Body (Catalog Number 9379) and Paradigm Regular Body VPS (Catalog Number 5315) impression materials. These products are intended to reproduce the structure of a patient's teeth for dental procedures such as crowns, bridges, and dentures. The affected lots are N510884, N510889, and N511952.
The recall is being conducted because the moisture displacement feature in both products is greatly reduced. This defect may impact the quality of the dental impression taken by the dental professional. The agency has classified this as a Class II recall.
A total of 1,977 kits were distributed worldwide, including the United States, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, and the United Arab Emirates. Consumers and dental professionals should check their inventory for the specific lot codes listed above and stop using these products if they match the recalled lots.
The recalled product
- Product
- 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression…
- Manufacturer
- 3M Company - Health Care Business
- Affected units
- 1,977
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 (3)
- Lot codes: N510884
- N510889
- and N511952
Distribution
Distributed nationwide across the United States.
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