Infinix Universal Composite
Infinix Universal Composite is a light-cured, resin-based material used to restore prepared tooth cavities. Its indications include Class I and II posterior restorations, Class III and IV…
Infinix Universal Composite is a light-cured, resin-based material used to restore prepared tooth cavities. Its indications include Class I and II posterior restorations, Class III and IV anterior restorations, and Class V defects such as cervical caries, root erosion and wedge-shaped lesions.
A bonding system is applied to the cavity before the composite filling material. Light-induced polymerization hardens the resin into the restoration. The composite contains inorganic filler particles, including silica-based particles carrying quaternary ammonium groups bound through a silane linker.
Listed Item
Dental Composite – A1 shade Single dose
Additional Uses
The Universal formulation can also veneer discolored anterior teeth, splint mobile teeth, provide extended fissure sealing in molars and premolars, and repair composite or ceramic veneers.
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 |
| Record revised | 2024-12-02 (version 2) |
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, carton box of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| INF-UC-PP-MD-A3 | In distribution | ||
| INF-UC-PP-MD-B1 | In distribution | ||
| INF-UC-PP-MD-A2 | In distribution | ||
| INF-UC-FP-SD-A1 | 20 | In distribution | |
| INF-UC-FP-SD-A3 | 20 | In distribution | |
| INF-UC-FP-SD-A2 | 20 | In distribution | |
| INF-UC-FP-SD-TR | 20 | In distribution | |
| INF-UC-FP-SD-B1 | 20 | In distribution | |
| INF-UC-PP-MD-A1 | In distribution | ||
| INF-UC-PP-MD-TR | 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.