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Precisil Jumbo Monophase
Sherpakorea · Model Precisil Jumbo Monophase (360ml * 2Cartridges) · UDI-DI 08800024201023
10
510(k) clearances
369
Adverse events
14
Recalls
147
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-18 | Clinician's Choice Dental Products Inc. | Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK |
| 2016-11-09 | Ivoclar Vivadent, Inc. | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
| 2016-11-09 | Ivoclar Vivadent, Inc. | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
| 2016-11-09 | Ivoclar Vivadent, Inc. | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
| 2013-11-21 | 3M Company - Health Care Business | 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 t |
| 2013-02-04 | Ultradent Products, Inc. | Incorrect packaging of regular set and fast set cartridges. |
| 2013-02-04 | Ultradent Products, Inc. | Incorrect packaging of regular set and fast set cartridges. |
| 2012-02-21 | Kerr Corporation | The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this pro |
| 2010-11-04 | Sybron Dental Specialties | Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium |
| 2004-10-13 | Harry J Bosworth Company | The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.