Darby Dental Supply, LLC
Polyvinylsiloxane Bite Registration Material Tubes Base & Catalyst
6manufacturers in China registered for this device type
124catalogue 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 | Darby Dental Supply, LLC |
|---|---|
| FDA product code | ELW |
| Device type | Material, Impression |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3660 |
| 510(k) | K992001 |
| Record published | 2016-07-20 |
| Record revised | 2020-09-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry.; Storage environment temperature 18 to 29 °C |
| Sizes | Weight 10 kg; weight 454 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9514784 | 4 | In distribution | |
| 5252756 | 2 | In distribution | |
| 5252788 | 4 | In distribution | |
| 9515183 | 2 | In distribution | |
| 9514775 | In distribution | ||
| 5252769 | 4 | In distribution | |
| 9514858 | In distribution | ||
| 5252795 | In distribution | ||
| 9514786 | 4 | In distribution | |
| 9514761 | 4 | In distribution | |
| 9514757 | 4 | In distribution | |
| 5252781 | 4 | In distribution | |
| 9514767 | 4 | In distribution | |
| 9515196 | 2 | In distribution | |
| 5252791 | 4 | In distribution | |
| 9430701 | 8 | In distribution | |
| 5252782 | 4 | In distribution | |
| 9500420 | Weight 10 kg | In distribution | |
| 9515192 | 2 | In distribution | |
| 9514776 | In distribution | ||
| 5252792 | 4 | In distribution | |
| 9514763 | In distribution | ||
| 5252751 | 2 | In distribution | |
| 5252762 | 32 | In distribution | |
| 5252750 | 2 | In distribution | |
| 5252796 | In distribution | ||
| 5252787 | 4 | In distribution | |
| 5252749 | 2 | In distribution | |
| 5252801 | 8 | In distribution | |
| 5252773 | 4 | In distribution | |
| 5252752 | 2 | In distribution | |
| 5252776 | 4 | In distribution | |
| 5252016 | 2 | In distribution | |
| 9514788 | 4 | In distribution | |
| 5252784 | 32 | In distribution | |
| 9516324 | 32 | In distribution | |
| 9504755 | In distribution | ||
| 9514769 | 4 | In distribution | |
| 9516326 | 32 | In distribution | |
| 9430700 | 8 | In distribution | |
| 5252755 | 2 | In distribution | |
| 5251979 | 2 | In distribution | |
| 9514862 | In distribution | ||
| 5252800 | 2 | In distribution | |
| 9515182 | 2 | In distribution | |
| 5252764 | 4 | In distribution | |
| 5252786 | 4 | In distribution | |
| 9515194 | 2 | In distribution | |
| 5252778 | 4 | In distribution | |
| 5252780 | 2 | In distribution | |
| 9516323 | 4 | In distribution | |
| 5252765 | 4 | In distribution | |
| 5252770 | 32 | In distribution | |
| 5252802 | 2 | In distribution | |
| 9500415 | Weight 454 g | In distribution | |
| 9514791 | In distribution | ||
| 9524744 | 2 | In distribution | |
| 5252799 | 8 | In distribution | |
| 5252754 | 2 | In distribution | |
| 5251980 | 2 | In distribution | |
| 9514768 | 4 | In distribution | |
| 5251978 | 2 | In distribution | |
| 9514764 | 4 | In distribution | |
| 9524756 | 2 | In distribution | |
| 5252760 | 4 | In distribution | |
| 5252767 | 4 | In distribution | |
| 9514863 | In distribution | ||
| 5252759 | 4 | In distribution | |
| 5252766 | 32 | In distribution | |
| 9514869 | In distribution | ||
| 5252789 | 32 | In distribution | |
| 9514861 | In distribution | ||
| 9514866 | In distribution | ||
| 5252794 | In distribution | ||
| 5252748 | 2 | In distribution | |
| 9514758 | 4 | In distribution | |
| 5252775 | 2 | In distribution | |
| 9514785 | 4 | In distribution | |
| 5252783 | 4 | In distribution | |
| 9514773 | 4 | In distribution | |
| 9515198 | 2 | In distribution | |
| 9516322 | 4 | In distribution | |
| 9524746 | 2 | In distribution | |
| 9516320 | 4 | In distribution | |
| 5252771 | 4 | In distribution | |
| 5252768 | 4 | In distribution | |
| 5252757 | 4 | In distribution | |
| 5252753 | 2 | In distribution | |
| 9514868 | In distribution | ||
| 5252772 | 4 | In distribution | |
| 9500425 | Weight 10 kg | In distribution | |
| 9514787 | 4 | In distribution | |
| 9500410 | 12 cans, 454 g each | In distribution | |
| 9514774 | 4 | In distribution | |
| 9516321 | 4 | In distribution | |
| 5252779 | 32 | In distribution | |
| 5252758 | 32 | In distribution | |
| 9516327 | 32 | In distribution | |
| 5252763 | 4 | In distribution | |
| 5252793 | In distribution | ||
| 5252022 | 2 | In distribution | |
| 9535584 | In distribution | ||
| 5252790 | 2 | In distribution | |
| 9514778 | 4 | In distribution | |
| 5252774 | 32 | In distribution | |
| 9514783 | 4 | In distribution | |
| 9514865 | In distribution | ||
| 5255911 | In distribution | ||
| 5252777 | 4 | In distribution | |
| 5252785 | 2 | In distribution | |
| 5252798 | In distribution | ||
| 9514766 | 4 | In distribution | |
| 9516325 | 32 | In distribution | |
| 9514765 | 4 | In distribution | |
| 9514867 | In distribution | ||
| 9514762 | 4 | In distribution | |
| 9514864 | In distribution | ||
| 5252797 | In distribution | ||
| 9514792 | In distribution | ||
| 9514860 | In distribution | ||
| 5251977 | 2 | In distribution | |
| 9514789 | 4 | In distribution | |
| 5255910 | In distribution | ||
| 5252761 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 164 |
| 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 |
| Futar | Kettenbach Gmbh & Co KG | 42 |
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.