Recall Z-0535-2014— 3M Company - Health Care Business

Name: FDA recall Z-0535-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-21

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2013-11-21, terminated 2014-06-02. It names one FDA 510(k) clearance: K000591. 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 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..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Terminated: 2014-06-02
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K000591 — DIMENSION PENTA H, DIMENSION PENTA H QUICKEspe Dental AG·cleared 2000-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.