Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

3M ESPE Imprint II Regular Body Recalled by 3M Company - Health Care Business Due to Specific lots of Imprint II and Paradigm impression...

Date: November 21, 2013
Company: 3M Company - Health Care Business
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 3M Company - Health Care Business directly.

Affected Products

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 materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.

Quantity: 1977 kits

Why Was This Recalled?

Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About 3M Company - Health Care Business

3M Company - Health Care Business has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report