Amelogen Plus
Amelogen Plus Syringe Enamel Neutral Refill
10manufacturers in China registered for this device type
74catalogue numbers in this listing
17510(k) clearances naming this product code
4recalls on this code
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 | Ultradent Products 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) | K043119 |
| Record published | 2016-09-22 |
| Record revised | 2018-09-05 (version 4) |
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 18 to 29 °C |
| Distribution end date | 2018-09-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8014 | In distribution | |
| 9028 | In distribution | |
| 9040 | In distribution | |
| 8017 | In distribution | |
| 8013 | In distribution | |
| 8012 | In distribution | |
| 315 | In distribution | |
| 8020 | In distribution | |
| 9036 | In distribution | |
| 8010 | In distribution | |
| 9040 | In distribution | |
| 9030 | In distribution | |
| 8020 | In distribution | |
| 8016 | In distribution | |
| 9032 | In distribution | |
| 8026 | In distribution | |
| 9032 | In distribution | |
| 8017 | In distribution | |
| 9037 | In distribution | |
| S3020 | In distribution | |
| 9035 | In distribution | |
| 9033 | In distribution | |
| 9041 | In distribution | |
| 8021 | In distribution | |
| 9038 | In distribution | |
| 9039 | In distribution | |
| 8018 | In distribution | |
| 9036 | In distribution | |
| 9038 | In distribution | |
| 9030 | In distribution | |
| 9043 | In distribution | |
| 8011 | In distribution | |
| 9037 | In distribution | |
| 8021 | In distribution | |
| 8010 | In distribution | |
| 9028 | In distribution | |
| 8022 | In distribution | |
| 8023 | In distribution | |
| 8016 | In distribution | |
| 8011 | In distribution | |
| 3098 | In distribution | |
| 9041 | In distribution | |
| 9039 | In distribution | |
| 8019 | In distribution | |
| 8024 | In distribution | |
| 9033 | In distribution | |
| 8019 | In distribution | |
| 9042 | In distribution | |
| 8022 | In distribution | |
| 8018 | In distribution | |
| 315 | In distribution | |
| 8014 | In distribution | |
| 8013 | In distribution | |
| 9042 | In distribution | |
| 9034 | In distribution | |
| 9035 | In distribution | |
| 9031 | In distribution | |
| S3020 | In distribution | |
| 9043 | In distribution | |
| 3098 | In distribution | |
| 315 | In distribution | |
| 9034 | In distribution | |
| 8023 | In distribution | |
| 8012 | In distribution | |
| 8026 | In distribution | |
| 8024 | In distribution | |
| 8015 | In distribution | |
| 3098 | In distribution | |
| 9031 | In distribution | |
| 8015 | In distribution | |
| 3209 | Withdrawn | |
| 4525 | Withdrawn | |
| 3013 | Withdrawn | |
| 3254 | 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 |
|---|---|
| K262228 | 2026-07-01 |
| K240694 | 2024-03-15 |
| K221909 | 2022-07-01 |
| K151094 | 2015-07-21 |
| K043119 | 2004-12-17 |
| K974413 | 1998-02-02 |
| K974282 | 1998-01-29 |
| K971898 | 1997-06-24 |
| K965060 | 1997-01-31 |
| K953525 | 1995-08-28 |
| K950859 | 1995-03-23 |
| K932227 | 1993-09-13 |
| K931867 | 1993-09-09 |
| K921598 | 1992-09-09 |
| K921602 | 1992-09-09 |
| K921407 | 1992-09-09 |
| K921409 | 1992-09-09 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 560 | |
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 2450 | |
| 2024-08-02 | Class II | Material/Component Contamination | Due to a manufacturing issue, red particulates present in the expressed composite. | 90 | |
| 2020-08-31 | Class II | Under Investigation by firm | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. | 412 syringes (206 kits) | 2021-10-18 |
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.