FDA Device recall Z-0811-2013
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. U…
- FDA Device
- Class III
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class III recall of Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. U… by Ultradent Products, citing incorrect packaging of regular set and fast set cartridges.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0811-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-04 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ultradent Products |
| Distribution | US |
Product
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Reason
Incorrect packaging of regular set and fast set cartridges.
Identifiers
| code_info | Part No. 5012, Lot No. B7PPC |
|---|
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 Ultradent Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0811-2013%22
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