HySil Super Fast Impression Materials
HySil Super Fast Impression Materials reproduce the shape of teeth and gums for dental restorative work. They are addition-curing elastomeric materials with hydrophilic properties. The…
HySil Super Fast Impression Materials reproduce the shape of teeth and gums for dental restorative work. They are addition-curing elastomeric materials with hydrophilic properties.
The material is placed in an impression tray or injected into the mouth according to the selected technique. Heavy, medium and light viscosities are supplied in 50 mL cartridges using a 1:1 delivery system.
Viscosity Options
Heavy material serves as a tray material in one- or two-step techniques. Mono provides a medium-bodied tray or syringeable option, while Light is syringeable for wash and related impression techniques. These options support work such as crowns, bridges, dentures and implant restorations. The materials are supplied nonsterile.
Who Else Makes It
Concentrated in Henan (1), Shandong (1), Jiangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hygedent Inc. | Beijing | Beijing | Contract manufacturer | 1 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Sunrise Dental Laboratory, Ltd. | Kowloon | Hong Kong | Manufacturer | 5 |
| Chemoment Materials Co., Ltd. | Hefei | Anhui | Manufacturer | 3 |
Record
| Listed by | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K192941 |
| Record published | 2020-11-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESS50LFB | In distribution | |
| ESS50HF | In distribution | |
| ESS50MF | In distribution | |
| ESS50LF | In distribution | |
| ESS50LFD | In distribution | |
| ESS50HFD | In distribution | |
| ESS50MFB | In distribution | |
| ESS50HFB | In distribution | |
| ESS50MFD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 124 |
| EXAlence™ | GC America Inc. | 96 |
| MARK3 | Cargus International, Inc | 75 |
| Panasil | Kettenbach Gmbh & Co KG | 73 |
| Aquasil Ultra Smart Wetting® Impression Material Cartridge System | Dentsply LLC | 72 |
| DentMix | IPB Inc | 70 |
| Affinis | Coltène/Whaledent AG | 67 |
| Take 1 Advanced | Kerr Corporation | 54 |
| MDC Dental | MDC Dental | 49 |
| Elastomeric Impression Material | Shandong Huge Dental Material Corporation | 46 |
| Splash® | DEN-MAT Holdings, LLC | 44 |
Showing 12 of 1,245. All products under Material, Impression
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210041 | 2021-03-18 |
| K192941 | 2020-01-30 |
| K181236 | 2018-09-13 |
| K170736 | 2017-06-07 |
| K151262 | 2015-09-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.