BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0535-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0535-2014
    Event ID
    66944
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    November 21, 2013
    Classification Date
    December 18, 2013
    Termination Date
    June 2, 2014
    Address
    3M Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144, United States

    Description

    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.

    Reason

    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.

    Code Info

    Lot codes: N510884, N510889, and N511952

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.

    Quantity

    1977 kits