FDA-Device2013-12-25Class II
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.
3M Company - Health Care Business
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
Affected count
1977 kits
Manufactured in
3M Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2014Don't want to check this manually?
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