SciPharm CuRay Fil Light Cure Composite Resin
Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class II Restorations. Dentin Enamel Bonding System. Non-Boxed.
10manufacturers in China registered for this device type
69catalogue numbers in this listing
29510(k) clearances naming this product code
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 | Scientific Pharmaceuticals, 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, Manufacturer |
| 510(k) | K823510 |
| Record published | 2016-07-28 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 75 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP 50-105 BS | In distribution | |
| SP 50-110 N | In distribution | |
| SP 50-104 B | In distribution | |
| SP 50-114 BS | In distribution | |
| SP 50-106 C | In distribution | |
| SP 50-104 CB | In distribution | |
| SP 50-106 B | In distribution | |
| SP 50-115 BS | In distribution | |
| SP 50-104 C | In distribution | |
| SP 50-107 N | In distribution | |
| SP 50-112 BS | In distribution | |
| SP 50-102 CBS | In distribution | |
| SP 50-114 CBS 20 | In distribution | |
| SP 50-113 B | In distribution | |
| SP 50-106 N | In distribution | |
| SP 50-114 N | In distribution | |
| SP 50-112 C | In distribution | |
| SP 50-105 C | In distribution | |
| SP 50-115 C | In distribution | |
| SP 50-115 CB | In distribution | |
| SP 50-107 B | In distribution | |
| SP 55-10 S | In distribution | |
| SP 50-103 B | In distribution | |
| SP 50-106 CBS 20 | In distribution | |
| SP 50-103 BS | In distribution | |
| SP 55-101 | In distribution | |
| SP 50-105 CBS 20 | In distribution | |
| SP 50-110 B | In distribution | |
| SP 50-102 C | In distribution | |
| SP 50-114 B | In distribution | |
| SP 50-106 CB | In distribution | |
| SP 50-103 C | In distribution | |
| SP 50-103 CBS 20 | In distribution | |
| SP 50-109 B | In distribution | |
| SP 50-105 CB | In distribution | |
| SP 50-106 BS | In distribution | |
| SP 50-103 CBS | In distribution | |
| SP 50-105 N | In distribution | |
| SP 50-102 B | In distribution | |
| SP 50-114 CB | In distribution | |
| SP 50-102 N | In distribution | |
| SP 50-104 BS | In distribution | |
| Sp 50-114 C | In distribution | |
| SP 50-112 B | In distribution | |
| SP 50-107 BS | In distribution | |
| SP 50-10 | In distribution | |
| SP 50-112 | In distribution | |
| SP 50-101 BS | In distribution | |
| SP 50-107 C | In distribution | |
| SP 50-115 CB 20 | In distribution | |
| SP 50-103 CB | In distribution | |
| SP 50-115 N | In distribution | |
| SP 50-101 CB | In distribution | |
| SP 50-102 CB | In distribution | |
| SP 50-113 N | In distribution | |
| SP 50-101 N | In distribution | |
| SP 50-105 B | In distribution | |
| SP 50-113 BS | In distribution | |
| SP 50-109 N | In distribution | |
| SP 50-113 C | In distribution | |
| SP 50-104 N | In distribution | |
| SP 50-112 CB | In distribution | |
| SP 55-10 C | In distribution | |
| SP 50-115 B | In distribution | |
| SP 50-113 CB | In distribution | |
| SP 55-102 | In distribution | |
| SP 50-101 C | In distribution | |
| SP 50-107 CB | In distribution | |
| SP 50-102 BS | 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 |
|---|---|
| K930584 | 1994-02-22 |
| K930583 | 1994-02-22 |
| K912788 | 1991-08-23 |
| K903551 | 1990-10-05 |
| K884391 | 1989-01-03 |
| K884350 | 1989-01-03 |
| K884681 | 1989-01-03 |
| K884351 | 1988-12-28 |
| K884352 | 1988-12-22 |
| K883392 | 1988-10-18 |
| K872890 | 1987-08-03 |
| K872569 | 1987-07-21 |
| K863401 | 1986-11-13 |
| K863031 | 1986-09-22 |
| K862648 | 1986-07-18 |
| K860626 | 1986-04-08 |
| K860627 | 1986-03-26 |
| K833810 | 1984-02-21 |
| K834247 | 1984-02-10 |
| K832781 | 1983-10-19 |
| K823510 | 1982-12-28 |
| K801797 | 1980-08-07 |
| K801798 | 1980-08-07 |
| K800439 | 1980-03-12 |
| K792140 | 1979-11-30 |
| K791602 | 1979-11-27 |
| K790822 | 1979-07-06 |
| K790963 | 1979-07-06 |
| K790789 | 1979-07-06 |
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.