Alpha II® AP
Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and…
Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and wear-resistant; making it ideal for Class I and II restorations yet highly polishable for use in all Class III, IV and V restorations. Alpha II® AP has optimal handling characteristics. The material can be easily manipulated without sticking to your instruments. Alpha II® contains fluorescence to provide a duplication of the natural tooth surface. Kit contains: 3 x 4g Composite Syringe, 1 x 4g Alpha-Etch®, 3ml Alpha-Bond®, Brushes, Applicator Tips, Dispensing Pad
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 | Dental Technologies, Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K904813 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
| Distribution end date | 2016-09-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 102.0701.002 | In distribution | ||
| 102.1601.002 | In distribution | ||
| 102.0802.002 | 15 | In distribution | |
| 102.1102.002 | 15 | In distribution | |
| 102.1401.002 | In distribution | ||
| 102.1701.002 | In distribution | ||
| 102.1202.002 | 15 | In distribution | |
| 102.1501.002 | In distribution | ||
| 102.0601.002 | In distribution | ||
| 102.1901.002 | In distribution | ||
| 102.0201.002 | In distribution | ||
| 102.0901.002 | In distribution | ||
| 102.1502.002 | 15 | In distribution | |
| 102.0101.002 | In distribution | ||
| 102.1602.002 | 15 | In distribution | |
| 102.0301.002 | In distribution | ||
| 102.0602.002 | 15 | In distribution | |
| 102.0702.002 | 15 | In distribution | |
| 102.1002.002 | 15 | In distribution | |
| 102.1101.002 | In distribution | ||
| 102.0302.002 | 15 | In distribution | |
| 102.0902.002 | 15 | In distribution | |
| 102.0501.002 | In distribution | ||
| 102.1201.002 | In distribution | ||
| 102.0202.002 | 15 | In distribution | |
| 102.1902.002 | 15 | In distribution | |
| 102.1402.002 | 15 | In distribution | |
| 102.0008.002 | In distribution | ||
| 102.1702.002 | 15 | In distribution | |
| 102.0402.002 | 15 | In distribution | |
| 102.1001.002 | In distribution | ||
| 102.0102.002 | 15 | In distribution | |
| 102.0401.002 | In distribution | ||
| 102.0801.002 | In distribution | ||
| 102.0502.002 | 15 | Withdrawn |
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 |
|---|---|
| K070191 | 2007-03-07 |
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.