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Precisil Premium Light Body

Sherpakorea · Model Precisil Premium Light Body (50ml * 2Cartridges) · UDI-DI 08800024201009

ELW

510(k) clearances

369

Adverse events

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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Data 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.