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PEAKOSIL
NEOSIL Co., Ltd · Model MSP · UDI-DI 08800026400042
1
510(k) clearances
369
Adverse events
14
Recalls
147
Facilities
Description
Product Name: Putty This product has another model number, NS005P which is registered in other countries. This product has a convenience kit, NS005P-1 that only changed only in packaging materials which don't cause any change from the original functions. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
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.