Ultradent Products — Class III medical device recall Z-0811-2013
Terminated recall by Ultradent Products, Inc., reported 2013-02-20, distributed nationwide. Incorrect packaging of regular set and fast set cartridges.
| Recall number | Z-0811-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2013-02-04 |
| Classified | 2013-02-13 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 32 cartridges |
| Lot numbers | B7PPC |
| Model numbers | 5012 |
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 for recall
Incorrect packaging of regular set and fast set cartridges.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0811-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.