Vittra APS Unique
Vittra APS Unique is a light-curing composite for direct restorations in front and back teeth. It is indicated for cavity Classes I through VI in permanent and primary teeth, using a shade…
Vittra APS Unique is a light-curing composite for direct restorations in front and back teeth. It is indicated for cavity Classes I through VI in permanent and primary teeth, using a shade approach intended to serve across dental shades.
The composite is radiopaque and contains inorganic filler particles averaging 0.8 to 0.9 micrometers. Its APS photoinitiator system combines several initiators that respond to the curing light to polymerize the resin.
Listed Item
Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The optical properties of Vittra APS Unique come from a fine balance between refractive indices of the dental structure versus that of the resin, which results in the propagation of the base color (dental remnant) through the resin structure. This effect causes the resin to “assume” (or transmit) the tooth color. It has a fundamental role, the loads, the well-balanced opacity of the product and the aesthetic of the APS system.
Material Composition
The formulation contains 72% to 80% inorganic filler by weight and 52% to 60% by volume. It does not contain Bis-GMA or Bis-EMA. The listed supply formats include 2 g, 4 g and capsule presentations.
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 | Dentscare Ltda, Brazil |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K210231 |
| Record published | 2022-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2g | In distribution | |
| Caps | In distribution | |
| 4g | 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 |
|---|---|
| K232994 | 2024-10-18 |
| K210231 | 2021-10-14 |
| K201707 | 2020-12-22 |
| K191389 | 2020-02-25 |
| K191306 | 2019-12-16 |
| K190758 | 2019-09-04 |
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.