Filtek™
3M™ ESPE™ Filtek™ Supreme Ultra Universal Restorative Amber Translucent Shade Refill, 1 - 4g Syringe - Amber, 6028AT
10manufacturers in China registered for this device type
188catalogue numbers in this listing
18510(k) clearances naming this product code
1recall
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 | 3M Company, 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 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Distribution end date | 2017-02-13 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6032C2 | In distribution | ||
| 4720B2 | In distribution | ||
| 6033W | 20 | In distribution | |
| 6029C1B | 20 | In distribution | |
| 6021A2 | 20 | In distribution | |
| 4861U | 15 | In distribution | |
| 4864A2 | 20 | In distribution | |
| 4866SP | In distribution | ||
| 6028D3B | In distribution | ||
| 6029B1E | 10 | In distribution | |
| 4866B1 | In distribution | ||
| 4720A3 | In distribution | ||
| 4866A2 | In distribution | ||
| 6032B1 | In distribution | ||
| 6029WB | 20 | In distribution | |
| 6020A4 | In distribution | ||
| 4866A2S | In distribution | ||
| 6028B3B | In distribution | ||
| 6029A3B | 20 | In distribution | |
| 6028A3E | In distribution | ||
| 4866C2 | In distribution | ||
| 4861A2 | 15 | In distribution | |
| 6028A6B | In distribution | ||
| 4862A2 | In distribution | ||
| 6029D2B | 20 | In distribution | |
| 6020I | In distribution | ||
| 4720B2 | In distribution | ||
| 4864C2 | 20 | In distribution | |
| 6028XWE | In distribution | ||
| 4867C2 | 20 | In distribution | |
| 6021A1 | 20 | In distribution | |
| 4867A2S | 5 | In distribution | |
| 6020A1 | In distribution | ||
| 4863A3 | In distribution | ||
| 4720C2 | In distribution | ||
| 4867B1 | 20 | In distribution | |
| 6033B1 | 20 | In distribution | |
| 6033A4 | 20 | In distribution | |
| 6029A2D | 10 | In distribution | |
| 6020C2 | In distribution | ||
| 6028AT | In distribution | ||
| 4866A1 | In distribution | ||
| 6033A1 | 20 | In distribution | |
| 6028B5B | In distribution | ||
| 6020UD | In distribution | ||
| 6032OA3 | In distribution | ||
| 6028WE | In distribution | ||
| 6029XWB | 20 | In distribution | |
| 6021B3 | 20 | In distribution | |
| 4862U-S | In distribution | ||
| 4863B1 | In distribution | ||
| 4867A3 | 20 | In distribution | |
| 6029D2E | 10 | In distribution | |
| 6028A4D | In distribution | ||
| 6028C2B | In distribution | ||
| 6033A3.5 | 20 | In distribution | |
| 6021I | 20 | In distribution | |
| 4720A3 | In distribution | ||
| 6028B1B | In distribution | ||
| 6020D3 | In distribution | ||
| 6021B2 | 20 | In distribution | |
| 6028D2B | In distribution | ||
| 6029B3B | 20 | In distribution | |
| 6033A2-S | 20 | In distribution | |
| 6020A3.5 | In distribution | ||
| 4861U-S | In distribution | ||
| 6029C2B | 20 | In distribution | |
| 6028SU | In distribution | ||
| 6021A3 | 20 | In distribution | |
| 6029B1B | 20 | In distribution | |
| 6033A3 | 20 | In distribution | |
| 4862A3 | In distribution | ||
| 6028A3D | In distribution | ||
| 6032A1 | In distribution | ||
| 4864A3 | 20 | In distribution | |
| 6028B1E | In distribution | ||
| 6029C4D | 10 | In distribution | |
| 4862U | In distribution | ||
| 6028A3B | In distribution | ||
| 6028C4D | In distribution | ||
| 6028A3.5B | In distribution | ||
| 6021A3.5 | 20 | In distribution | |
| 6028C1B | In distribution | ||
| 6033C2 | 20 | In distribution | |
| 6028A2B | In distribution | ||
| 6029A4D | 10 | In distribution | |
| 6028XWB | In distribution | ||
| 6029A6B | 20 | In distribution | |
| 6032W | In distribution | ||
| 6028WD | In distribution | ||
| 6028A1E | In distribution | ||
| 6029B3D | 10 | In distribution | |
| 6020B2 | In distribution | ||
| 6028GT | In distribution | ||
| 6029B2E | 10 | In distribution | |
| 4864A1 | 20 | In distribution | |
| 6028A2D | In distribution | ||
| 6020B1 | In distribution | ||
| 6029CT | 10 | In distribution | |
| 6028A2E | In distribution | ||
| 6032D2 | In distribution | ||
| 6028BT | In distribution | ||
| 6021C2 | 20 | In distribution | |
| 6029C3B | 20 | In distribution | |
| 6029A3E | 10 | In distribution | |
| 6032B2 | In distribution | ||
| 6032A3.5 | In distribution | ||
| 4864A2-S | 5 | In distribution | |
| 6029XWE | 10 | In distribution | |
| 4863A2 | In distribution | ||
| 6029WD | 10 | In distribution | |
| 6029B5B | 20 | In distribution | |
| 4863A1 | In distribution | ||
| 6029WE | 10 | In distribution | |
| 6029D3B | 20 | In distribution | |
| 4862A1 | In distribution | ||
| 6029B2B | 20 | In distribution | |
| 6028WB | In distribution | ||
| 6029GT | 10 | In distribution | |
| 6029A3.5B | 20 | In distribution | |
| 6029A1E | 10 | In distribution | |
| 6033D2 | 20 | In distribution | |
| 4861A3 | 15 | In distribution | |
| 6029A3D | 10 | In distribution | |
| 6032A4 | In distribution | ||
| 6028D2E | In distribution | ||
| 6029A2B | 20 | In distribution | |
| 6029A4B | 20 | In distribution | |
| 6028B2E | In distribution | ||
| 6028A1D | In distribution | ||
| 6028A4B | In distribution | ||
| 6029A2E | 10 | In distribution | |
| 6032A2-S | 20 | In distribution | |
| 6021B1 | 20 | In distribution | |
| 6033B2 | 20 | In distribution | |
| 6028A1B | In distribution | ||
| 6029A1D | 10 | In distribution | |
| 6033A2 | 20 | In distribution | |
| 6028B2B | In distribution | ||
| 6032A2 | In distribution | ||
| 6029A1B | 20 | In distribution | |
| 6020A2 | In distribution | ||
| 6021UD | 20 | In distribution | |
| 6029BT | 10 | In distribution | |
| 4866A3 | In distribution | ||
| 4867A1 | 20 | In distribution | |
| 4867A2 | 20 | In distribution | |
| 6028CT | In distribution | ||
| 4861A1 | 15 | In distribution | |
| 6021A4 | 20 | In distribution | |
| 6020B3 | In distribution | ||
| 6033OA3 | 20 | In distribution | |
| 6032A3 | In distribution | ||
| 6028B3D | In distribution | ||
| 4863C2 | In distribution | ||
| 6021D3 | 20 | In distribution | |
| 6032XW | In distribution | ||
| 4720C2 | In distribution | ||
| 6029AT | 10 | In distribution | |
| 6033XW | 20 | In distribution | |
| 4864B1 | 20 | In distribution | |
| 6028C3B | In distribution | ||
| 6020A3 | In distribution | ||
| 6033A1 | 20 | Withdrawn | |
| 6033W | 20 | Withdrawn | |
| 6033A4 | 20 | Withdrawn | |
| 6032D2 | 20 | Withdrawn | |
| 6032W | 20 | Withdrawn | |
| 6033B2 | 20 | Withdrawn | |
| 6033XW | 20 | Withdrawn | |
| 6033A3.5 | 20 | Withdrawn | |
| 6033OA3 | 20 | Withdrawn | |
| 6033C2 | 20 | Withdrawn | |
| 6033A2 | 20 | Withdrawn | |
| 6032A3 | 20 | Withdrawn | |
| 6032A3.5 | 20 | Withdrawn | |
| 6032B1 | 20 | Withdrawn | |
| 6032A1 | 20 | Withdrawn | |
| 6032B2 | 20 | Withdrawn | |
| 6032OA3 | 20 | Withdrawn | |
| 6032XW | 20 | Withdrawn | |
| 6032A4 | 20 | Withdrawn | |
| 6032A2 | 20 | Withdrawn | |
| 6033B1 | 20 | Withdrawn | |
| 6033D2 | 20 | Withdrawn | |
| 6032C2 | 20 | Withdrawn | |
| 6032A2-S | 5 | Withdrawn | |
| 6033A3 | 20 | 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 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
| IPS Empress Direct | Ivoclar Vivadent Aktiengesellschaft | 147 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163207 | 2016-11-28 |
| K122569 | 2012-09-12 |
| K100235 | 2010-05-12 |
| K083610 | 2008-12-17 |
| K072733 | 2008-02-15 |
| K010781 | 2001-04-13 |
| K991961 | 1999-08-09 |
| K981647 | 1998-08-09 |
| K970500 | 1997-04-30 |
| K920425 | 1992-03-20 |
| K872444 | 1987-09-11 |
| K872279 | 1987-07-02 |
| K861899 | 1986-06-25 |
| K861740 | 1986-05-21 |
| K851459 | 1985-05-21 |
| K841550 | 1984-06-22 |
| K833797 | 1984-04-25 |
| K810595 | 1981-03-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-06-15 | Class II | Device Design | 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers. | 1.8 million (US 1,017,834) | 2016-04-26 |
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.