Darby Dental Supply, LLC
Compolite Nano Composite; Dentin/Body; Single Doses; A3.5; Refill
10manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| 510(k) | K833810 |
| Record published | 2016-06-09 |
| Record revised | 2025-10-09 (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 |
| Sizes | Weight 2.5 to 56 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9542872 | Weight 2.5 g | 10 | In distribution |
| DCBUW | In distribution | ||
| 9518490 | In distribution | ||
| 5255146 | 10 | In distribution | |
| DCBUN | In distribution | ||
| 9521206 | In distribution | ||
| 5255136 | In distribution | ||
| 5255141 | 10 | In distribution | |
| 5255148 | 10 | In distribution | |
| 9542850 | Weight 4 g | In distribution | |
| 5255142 | 10 | In distribution | |
| 9542852 | Weight 4 g | In distribution | |
| 9542874 | Weight 2.5 g | 10 | In distribution |
| 9520878 | 4 | In distribution | |
| 9519192 | In distribution | ||
| 9509040 | Weight 56 g | In distribution | |
| 9542848 | Weight 4 g | In distribution | |
| 9521127 | 20 | In distribution | |
| 9521209 | In distribution | ||
| 9542840 | Weight 4 g | In distribution | |
| 9542842 | Weight 4 g | In distribution | |
| 9509030 | In distribution | ||
| 9521126 | 20 | In distribution | |
| 9519066 | In distribution | ||
| 9521125 | 20 | In distribution | |
| 9542882 | Weight 2.5 g | 10 | In distribution |
| 5255138 | In distribution | ||
| 5255137 | In distribution | ||
| 9542846 | Weight 4 g | In distribution | |
| 9542844 | Weight 4 g | In distribution | |
| 9542870 | Weight 2.5 g | 10 | In distribution |
| 9521205 | In distribution | ||
| 9542876 | Weight 2.5 g | 10 | In distribution |
| 9509042 | Weight 28 g | In distribution | |
| 5255133 | In distribution | ||
| 9542884 | Weight 2.5 g | 10 | In distribution |
| 5255140 | In distribution | ||
| 9519067 | 4 | In distribution | |
| 5255139 | In distribution | ||
| 9519068 | 4 | In distribution | |
| 9542854 | Weight 4 g | In distribution | |
| 9542880 | Weight 2.5 g | 10 | In distribution |
| 9542878 | Weight 2.5 g | 10 | In distribution |
| 9521207 | In distribution | ||
| 5255134 | In distribution | ||
| 5255143 | 10 | In distribution | |
| 5255145 | 10 | In distribution | |
| 5255135 | In distribution | ||
| 5251888 | 4 | In distribution | |
| 9518485 | In distribution | ||
| 9521208 | In distribution | ||
| 9509043 | Weight 28 g | In distribution | |
| 5255147 | 10 | In distribution | |
| 5255144 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
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.