Z-0535-2014Class II

3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315...

Name: Z-0535-2014 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315...
Creator: 3M Company - Health Care Business
Published: 2013-11-21
License: https://open.fda.gov/license/

3M Company / initiated 2013-11-21 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce... on 2013-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0535-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2013-12-18
Terminated: 2014-06-02
Recalling firm: 3M Company
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.
Product code: ELW Material, Impression
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 3M ESPE sent an Voluntary Recall Notification Letter dated November 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to: 1) Review your inventory and identify any products from these lot numbers 2) Quarantine products from these lots and do not further distribute 3) If you have shipped any products from these lots to your customers, inform them of this voluntary recall using the attached Dear Doctor Letter and Inventory Checklist 4) To return and replace product from these lots, contact 3M ESPE Dental Products Customer Service at 1-800-237-1650 If you have any questions, please contact the above number for assistance. Once again, we sincerely apologize for any inconvenience this may cause you.
Quantity in commerce: 1977 kits
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
Product codes and lots: Lot codes: N510884, N510889, and N511952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0535-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-18

Product code ELW

K000591Class IIDimension Penta H, Dimension Penta H QuickEspe Dental AG / cleared 2000-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)