HySil Impression Materials
HySil Impression Materials are addition-curing elastomeric dental materials for taking impressions. The family includes putty, heavy, mono, light and extra-light viscosities, plus a…
HySil Impression Materials are addition-curing elastomeric dental materials for taking impressions. The family includes putty, heavy, mono, light and extra-light viscosities, plus a bite-registration formulation.
Impression materials are supplied in 1:1 50 mL automix cartridges or traditional 1:1 putty jars. Their hydrophilic formulation and range of consistencies support selection for different tray and wash roles.
Bite Registration
HySil Bite is an addition-curing silicone in a 50 mL cartridge for recording the relationship between the jaws. It sets quickly to a high final hardness with limited elastic deformation during removal. Putty formulations support one-step or two-step putty-wash impressions.
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) | K170736 |
| Record published | 2017-06-20 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| ESS50LD | In distribution | |
| ESS50L | In distribution | |
| ESS50MB | In distribution | |
| ESS50M | In distribution | |
| ESS50MB | In distribution | |
| ESS50HB | In distribution | |
| ESS50L | In distribution | |
| ESS50M | In distribution | |
| ESS400P | In distribution | |
| ESS50HD | In distribution | |
| ESS50MD | In distribution | |
| ESS50LB | In distribution | |
| ESS50H | In distribution | |
| ESS50EL | In distribution | |
| ESS400P | In distribution | |
| ESS50HB | In distribution | |
| ESS50H | In distribution | |
| ESS50EL | In distribution | |
| ESS50LB | 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.