HySil Impression Materials (Heavy, Mono, and Bite)
HySil Heavy, Mono and Bite are dental materials for recording tooth and gum structures or the way the teeth meet. Heavy is a heavy-bodied impression material, Mono is a medium-bodied tray…
HySil Heavy, Mono and Bite are dental materials for recording tooth and gum structures or the way the teeth meet. Heavy is a heavy-bodied impression material, Mono is a medium-bodied tray or syringe material, and Bite is a silicone bite-registration material.
Heavy and Mono are addition-curing elastomers placed in a tray or delivered into the mouth according to the impression technique. They are available in 1:1, 50-millilitre automix cartridges and 5:1, 380-millilitre cartridges for compatible automatic dispensing and mixing equipment.
Bite Registration
HySil Bite is supplied in a 50-millilitre cartridge. It records or confirms occlusal surfaces and can be used for recording the bite relationship after placement on an articulator.
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) | K181236 |
| 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 |
|---|---|---|
| ESS380H | In distribution | |
| ESS380M | In distribution | |
| ESS50B | In distribution | |
| ESS380M | In distribution | |
| ESS380H | 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.