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Material, Impression
FDA product code ELW · Class 2 · Dental
4,803
Registered devices
371
Adverse events
14
Recalls
404
510(k) clearances
Devices with this code
Henry Schein — HENRY SCHEIN, INC.SKY SELECT — DANVILLE MATERIALS, LLCSTART VPS — DANVILLE MATERIALS, LLCEXAlence™ — Gc America Inc.Harvard PremiumSil Light Fast — Harvard Dental International GmbHOne Plus — Hexa DentalThermo Clone — ULTRADENT PRODUCTS, INC.Waterpik Key-To Alginate Impression Material — WATER PIK, INC.Panasil — Kettenbach GmbH & Co. KGFIRST QUARTER — DANVILLE MATERIALS, LLCEXAlence™ — Gc America Inc.Remi Impression Kit — GrindGuard Inc.Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATIONPrecisil Big — SherpakoreaHySil Plus Impression Materials — Osstem Implant Co.,Ltd.Splash® — DEN-MAT HOLDINGS, LLCMDC Dental — MDC DENTALAdvance Dental Products — The Atlanta Dental Supply CompanyBISICO S3 Heavy 2x170ml — bisico Bielefelder Dentalsilicone GmbH & Co. KGAquasil Ultimate Tissue Managing Wash Impression System — DENTSPLY INTERNATIONAL INC.Vivid Flavor Match Vanilla Fast Set Mono — PEARSON DENTAL SUPPLIES, INC.Express™ — 3M COMPANYSCOTT'S VPS HP FAST-SET LIGHT BODY 4/bx — SCOTT'S DENTAL SUPPLY L.L.C.Cavex Orthotrace — Cavex Holland B.V.
Recent 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 12 |
| 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 reduce |
| 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 rem |
| 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 |
| 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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