Home › Device types › ELW
Material, Impression
FDA product code ELW · Class 2 · Dental
4,751
Registered devices
369
Adverse events
14
Recalls
402
510(k) clearances
Devices with this code
GC CARTRIDGE DISPENSER II — Gc America Inc.AFFINIS — Coltène/Whaledent AGzetaplus — ZHERMACK SPAAquasil Ultra Heavy Fast Set Smart Wetting® Impression Material — DENTSPLY INTERNATIONAL INC.SCOTT'S VPS HP REG-SET LIGHT BODY 4/bx — SCOTT'S DENTAL SUPPLY L.L.C.Pac-Dent — PAC-DENT INTERNATIONAL INC3M™ Imprint™ II Penta™ — 3M Deutschland GmbHHySil Super Fast Impression Materials — Osstem Implant Co.,Ltd.AxioSil Putty — Axiodent Inc.Regisil® Rigid Super Fast Set Cartridge System — DENTSPLY INTERNATIONAL INC.Virtual — IVOCLAR VIVADENT AKTIENGESELLSCHAFTKromaFaze — Kerr CorporationAFFINIS — Coltène/Whaledent AGAFFINIS — Coltène/Whaledent AGEXAlence™ — Gc America Inc.Brasseler USA — Peter Brasseler Holdings, LLCImpregum™ Penta™ Soft Medium Body — 3M Deutschland GmbHDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCPrime Dent Tray Adhesive Blue — PRIME DENTALBosworth Fastray LC — Harry J Bosworth CompanyPrecisil Putty FS — SherpakoreaAquasil® Ultra+ Smart Wetting® Impression Material — DENTSPLY INTERNATIONAL INC.Vivid Flavor Match Berry Regular Set Heavy — PEARSON DENTAL SUPPLIES, INC.Vivid Elegance HTS Light RS — PEARSON DENTAL SUPPLIES, INC.
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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