Alpha-Dent® Light Cure Hybrid Composite
ALPHA-DENT® Light Cure Composite restorative is radiopaque. It has the versatility of the Hybrid composite while measuring high compressive strength with excellent polishablity. The…
ALPHA-DENT® Light Cure Composite restorative is radiopaque. It has the versatility of the Hybrid composite while measuring high compressive strength with excellent polishablity. The composite is appropriate for almost every type restoration. Kit contains: 7 x 4.5g Composite Syringes, 7ml Light Cure Bonding Resin, 2 x 4g Etchant Gel Syringes, Brushes, Brush Holder, Dispensing Pad
10manufacturers in China registered for this device type
41catalogue numbers in this listing
1510(k) clearance
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 | Dental Technologies, Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K904813 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 101.1001.001 | In distribution | ||
| 101.0603.001 | 15 | In distribution | |
| 101.0401.001 | In distribution | ||
| 101.0201.001 | In distribution | ||
| 101.1103.001 | 15 | In distribution | |
| 101.0203.001 | 15 | In distribution | |
| 101.0803.001 | 15 | In distribution | |
| 101.0001.001 | In distribution | ||
| 101.1003.001 | 15 | In distribution | |
| 101.0703.001 | 15 | In distribution | |
| 101.1503.001 | 15 | In distribution | |
| 101.0601.001 | In distribution | ||
| 101.0103.001 | 15 | In distribution | |
| 101.0301.001 | In distribution | ||
| 101.1403.001 | 15 | In distribution | |
| 101.0101.001 | In distribution | ||
| 101.1701.001 | In distribution | ||
| 101.0010.001 | In distribution | ||
| 101.0303.001 | 15 | In distribution | |
| 101.1101.001 | In distribution | ||
| 101.0007.001 | In distribution | ||
| 101.0002.001 | In distribution | ||
| 101.1703.001 | 15 | In distribution | |
| 101.1201.001 | In distribution | ||
| 101.1603.001 | 15 | In distribution | |
| 101.1901.001 | In distribution | ||
| 101.1401.001 | In distribution | ||
| 101.0701.001 | In distribution | ||
| 101.0801.001 | In distribution | ||
| 101.0403.001 | 15 | In distribution | |
| 101.0503.001 | 15 | In distribution | |
| 101.0003.001 | In distribution | ||
| 101.0008.001 | In distribution | ||
| 101.1501.001 | In distribution | ||
| 101.0901.001 | In distribution | ||
| 101.0000.001 | In distribution | ||
| 101.1601.001 | In distribution | ||
| 101.0903.001 | 15 | In distribution | |
| 101.0501.001 | In distribution | ||
| 101.1203.001 | 15 | In distribution | |
| 101.1903.001 | 15 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070191 | 2007-03-07 |
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.