Allcem Veneer APS
Allcem Veneer APS is a light-curing resin cement for adhesive placement of thin ceramic or composite restorations. It is intended for veneers and other highly translucent restorations up to…
Allcem Veneer APS is a light-curing resin cement for adhesive placement of thin ceramic or composite restorations. It is intended for veneers and other highly translucent restorations up to 1.5 mm thick that have no opaque underlying structure.
The single-component cement is supplied in a syringe and is used with an acid-etching and adhesive technique. Its APS system combines photoinitiators that respond to light from the curing unit.
Listed Item
Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure.
Shade Selection
Multiple cement shades are available, including the listed A1, A2, A3 and E-Bleach M presentations. A separate try-in accessory simulates the expected color effect before the final cement shade is selected; it is distinct from the light-curing cement.
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) | K191389 |
| Record published | 2020-09-14 |
| Record revised | 2024-02-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A2 2.5g | In distribution | |
| E-Bleach M 2.5g | In distribution | |
| Opaque White 2.5g | In distribution | |
| Trans 2.5g | In distribution | |
| A3 2.5g | In distribution | |
| A1 2.5g | In distribution | |
| Mini Kit | 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.