FDA Device recall Z-0535-2014
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are int…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are int… by 3m Health Care Business, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0535-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
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.
Identifiers
| code_info | Lot codes: N510884, N510889, and N511952 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All 3m Health Care Business recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2014%22
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