Estelite Universal Flow
Estelite Universal Flow is a light-cured, radiopaque composite resin for tooth restorations, cavity lining and repair of porcelain or composite. A photopolymerization initiator system…
Estelite Universal Flow is a light-cured, radiopaque composite resin for tooth restorations, cavity lining and repair of porcelain or composite. A photopolymerization initiator system activates curing when exposed to dental curing light.
The material combines a methacrylate resin matrix with spherical silica-zirconia and composite fillers. Its spherical filler particles average about 200 nm, with a 100 to 300 nm range.
Listed Item
SuperLow L-SYR A3.5
Flow and Delivery Forms
High, Medium and Super Low viscosities are supplied in syringes or preloaded tips. A listed Super Low syringe is one delivery configuration. The material is supplied nonsterile and is not intended to be sterilized before use.
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 | Tokuyama Dental Corporation, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| 510(k) | K180613 |
| Record published | 2018-08-09 |
| Record revised | 2024-11-04 (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 |
| Storage | Storage environment temperature 0 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 13992 | 20 | In distribution | |
| 13976 | 20 | In distribution | |
| 13986 | 20 | In distribution | |
| 13885 | In distribution | ||
| 13879 | In distribution | ||
| 13881 | In distribution | ||
| 13984 | 20 | In distribution | |
| 13990 | 20 | In distribution | |
| 13991 | 20 | In distribution | |
| 13893 | In distribution | ||
| 13882 | In distribution | ||
| 13890 | In distribution | ||
| 13995 | 20 | In distribution | |
| 13875 | In distribution | ||
| 13977 | 20 | In distribution | |
| 13989 | 20 | In distribution | |
| 13978 | 20 | In distribution | |
| 13993 | 20 | In distribution | |
| 13979 | 20 | In distribution | |
| 13998 | 20 | In distribution | |
| 13892 | In distribution | ||
| 13897 | In distribution | ||
| 13994 | 20 | In distribution | |
| 13886 | In distribution | ||
| 13876 | In distribution | ||
| 13887 | In distribution | ||
| 13884 | In distribution | ||
| 13895 | In distribution | ||
| 13988 | 20 | In distribution | |
| 13898 | In distribution | ||
| 13996 | 20 | In distribution | |
| 13899 | In distribution | ||
| 13999 | 20 | In distribution | |
| 13888 | In distribution | ||
| 13983 | 20 | In distribution | |
| 13975 | 20 | In distribution | |
| 13987 | 20 | In distribution | |
| 13880 | In distribution | ||
| 13891 | In distribution | ||
| 13980 | 20 | In distribution | |
| 13889 | In distribution | ||
| 13877 | In distribution | ||
| 13985 | 20 | In distribution | |
| 13894 | In distribution | ||
| 13981 | 20 | In distribution | |
| 13896 | In distribution | ||
| 13997 | 20 | In distribution | |
| 13883 | In distribution | ||
| 13878 | In distribution | ||
| 13982 | 20 | 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 |
|---|---|
| K203598 | 2021-02-03 |
| K193537 | 2020-08-19 |
| K180613 | 2018-07-12 |
| K173275 | 2018-02-27 |
| K161353 | 2017-04-03 |
| K110178 | 2011-04-05 |
| K080940 | 2008-06-19 |
| K072746 | 2007-12-04 |
| K051808 | 2005-08-08 |
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.