Infinix Flowable Composite
Infinix Flowable Composite is a light cured resin material used to restore small tooth defects and fill prepared cavities. Its uses include Class III and V restorations and small occlusal…
Infinix Flowable Composite is a light cured resin material used to restore small tooth defects and fill prepared cavities. Its uses include Class III and V restorations and small occlusal restorations that do not bear stress. It can also form a base or liner beneath a direct or indirect restoration.
The material combines resin with inorganic filler particles. Light exposure polymerizes the resin into a solid restoration, with specialized silica particles remaining within the cured material. The Flowable formulation has its own indications within the Infinix composite family.
Listed Item
Dental Composite – A2 shade Multi dose 2g for re-fills kits
Additional Uses
Listed uses include sealing pits and fissures, blocking out undercuts, repairing small defects in aesthetic indirect restorations, and repairing resin or acrylic temporary materials.
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-FL-FP-SD-A1 | 15 | In distribution | |
| INF-FL-PP-MD1G-A2 | In distribution | ||
| INF-FL-FP-SD-A2 | 15 | In distribution | |
| INF-FL-PP-MD2G-A2 | In distribution | ||
| INF-FL-FP-SD-A3 | 15 | In distribution | |
| INF-FL-PP-MD-A1 | In distribution | ||
| INF-FL-PP-MD-A3 | 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.