SureFil® SDR® Flow Posterior Bulk Fill Flowable Base
SureFil® SDR® flow Posterior Bulk Fill Flowable Base, Universal, 2 (1.0g) Syringe Refill
10manufacturers in China registered for this device type
6catalogue numbers in this listing
32510(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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2024-06-05 (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 |
| Storage | Special storage condition: Keep away from sunlight. |
| Sizes | Weight 0.25 to 1 g |
| Distribution end date | 2024-06-05 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 61C011 | 60 Applicator Needles | 60 | In distribution |
| 61C004 | 1 half-filled SureFil SDR Flow Universal syringe and 3 mix tips | Withdrawn | |
| 61C001 | 15 Compula® Tips -1 Shade (0,25g each) Universal Shade, Compula® Tips Cap Color White | 15 | Withdrawn |
| 61C000 | 25 Compula® Tips – Universal Shade (0.25g each), 1 Compules® Tips Gun | Withdrawn | |
| 61C130 | 2 syringes (1g each) and 15 syringe tips – universal shade | 2 | Withdrawn |
| 61C030 | 2 Syringes (1.0g each)-Universal Shade, 15 Syringe Tips | 2 | Withdrawn |
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 |
|---|---|
| K083841 | 2009-04-14 |
| K083326 | 2009-02-10 |
| K052097 | 2005-08-12 |
| K050880 | 2005-04-22 |
| K040144 | 2004-04-01 |
| K984387 | 1999-01-13 |
| K982318 | 1998-09-15 |
| K982395 | 1998-08-18 |
| K973221 | 1998-02-09 |
| K973235 | 1998-02-05 |
| K950991 | 1995-03-23 |
| K945769 | 1994-12-29 |
| K942031 | 1994-06-10 |
| K932395 | 1993-08-25 |
| K923236 | 1992-09-11 |
| K905476 | 1991-02-20 |
| K896564 | 1990-02-09 |
| K872907 | 1987-08-03 |
| K863552 | 1986-10-17 |
| K863174 | 1986-10-07 |
| K863092 | 1986-09-19 |
| K853431 | 1985-10-31 |
| K852659 | 1985-07-30 |
| K852658 | 1985-07-24 |
| K852151 | 1985-07-01 |
| K850911 | 1985-04-16 |
| K830442 | 1983-03-17 |
| K813357 | 1982-01-07 |
| K802975 | 1981-01-14 |
| K802125 | 1980-09-16 |
| K801732 | 1980-08-07 |
| K801092 | 1980-05-20 |
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.