Infinix Bulk Fill Flow Composite
Infinix Bulk Fill Flow Composite is a light-cured, resin-based dental restorative material. It can serve as a base under Class I and II direct restorations, a liner under restorative…
Infinix Bulk Fill Flow Composite is a light-cured, resin-based dental restorative material. It can serve as a base under Class I and II direct restorations, a liner under restorative materials, or a pit and fissure sealant. It is also indicated for selected minimally invasive cavity preparations.
Further applications include Class III and V restorations, blocking undercuts and repairing small enamel defects or small defects in esthetic indirect restorations. It can repair resin and acrylic temporary materials. Core build-up requires at least half of the coronal tooth structure to remain.
Listed Item
Dental Composite – Translucent Single dose
Filler Structure
Some silica filler particles carry covalently bound quaternary ammonium groups linked to the silica core. These QASi particles remain trapped within the composite after light polymerization. They comprise no more than 1.2% by weight of the total formulation; the resin and inorganic filler together form the restorative material.
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 | Nobio Ltd., Israel |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K201010 |
| Record published | 2021-03-15 |
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 | Carton box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| INF-BF-PP-MD-TR | In distribution | ||
| INF-BF-PP-MD-A3 | In distribution | ||
| INF-BF-FP-SD-A3 | 15 | In distribution | |
| INF-BF-FP-SD-TR | 15 | In distribution | |
| INF-BF-FP-SD-A2 | 15 | In distribution | |
| INF-BF-PP-MD-A2 | In distribution | ||
| INF-BF-PP-MD-A1 | In distribution | ||
| INF-BF-FP-SD-A1 | 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 |
|---|---|
| K201010 | 2020-08-14 |
| K182921 | 2019-09-13 |
| K182714 | 2019-07-12 |
| K182580 | 2019-07-03 |
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.