Enthus
Enthus VPS Impression Material, Putty, Regular Set, Spearmint Flavor, 1 x 300ml Base, 1 x 300ml Catalyst, 2 Spoons
6manufacturers in China registered for this device type
12catalogue numbers in this listing
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 | Dharma Research, Inc., United States |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| 510(k) | K041028 |
| Record published | 2016-10-07 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 23 °C |
| Packaging | Case of 12, case of 6 |
| Sizes | Total volume 50 to 600 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 38-00009 | Total Volume 50 ml | 4 | In distribution |
| 38-00003 | Total Volume 50 ml | 4 | In distribution |
| 38-00011 | Total Volume 50 ml | 2 | In distribution |
| 38-00002 | Total Volume 600 ml | In distribution | |
| 38-00007 | Total Volume 50 ml | 4 | In distribution |
| 38-00010 | Total Volume 50 ml | 4 | In distribution |
| 38-00006 | Total Volume 50 ml | 4 | In distribution |
| 38-00004 | Total Volume 50 ml | 4 | In distribution |
| 38-00008 | Total Volume 50 ml | 4 | In distribution |
| 38-00001 | Total Volume 600 ml | In distribution | |
| 38-00005 | Total Volume 50 ml | 4 | In distribution |
| 38-00012 | Total Volume 50 ml | 2 | 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
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.