Henry Schein
Natural Elegance is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth.
10manufacturers in China registered for this device type
110catalogue numbers in this listing
2recalls 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| 510(k) | K012160 |
| Record published | 2021-03-19 |
| Record revised | 2025-10-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 24 °C; Special storage condition: Keep out of sun; Storage environment temperature 50 to 75 °F |
| Packaging | Case of 60, inner pack of 40, case of 100, case of 30, pack of 2, case of 10 |
| Sizes | Weight 0.2 to 28 g; needle gauge 18 to 20 G; total volume 6 to 10 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5702567 | 20 | In distribution | |
| 9004001 | Syringe | In distribution | |
| 5702070 | 4 | In distribution | |
| 1048749 | 2 | In distribution | |
| 5702568 | 20 | In distribution | |
| 5702582 | In distribution | ||
| 5700128 | Weight 0.2 g | In distribution | |
| 1048780 | Syringe x 4 | In distribution | |
| 5701999 | In distribution | ||
| 5701370 | 50 | In distribution | |
| 5702460 | 4 | In distribution | |
| 1009350 | In distribution | ||
| 1048778 | Syringe Tip x 20 | In distribution | |
| 5700131 | Weight 0.2 g | In distribution | |
| 5702566 | 20 | In distribution | |
| 5702579 | In distribution | ||
| 1063002 | Weight 18 g | In distribution | |
| 5700133 | Weight 0.2 g | In distribution | |
| 5700132 | Single Use Predosed Tips x 20 | In distribution | |
| 9001462 | In distribution | ||
| 1005721 | In distribution | ||
| 1003314 | 20 | In distribution | |
| 1005056 | In distribution | ||
| 9004003 | Weight 4.5 g | In distribution | |
| 5702456 | 4 | In distribution | |
| 5701998 | In distribution | ||
| 9001586 | 2 | In distribution | |
| 1006927 | In distribution | ||
| 1126979 | In distribution | ||
| 5702570 | 20 | In distribution | |
| 1126978 | 2 | In distribution | |
| 1005607 | In distribution | ||
| 5700124 | Weight 0.2 g | In distribution | |
| 5702002 | In distribution | ||
| 1012772 | Syringe Tip x 20 | In distribution | |
| 1005217 | In distribution | ||
| 5702571 | 20 | In distribution | |
| 1015187 | Weight 2 g | In distribution | |
| 5702454 | 4 | In distribution | |
| 1048885 | Total Volume 10 ml | In distribution | |
| 1008050 | In distribution | ||
| 5702575 | 20 | In distribution | |
| 5703019 | In distribution | ||
| 5700135 | Single Use Predosed Tips x 20 | In distribution | |
| 5702003 | In distribution | ||
| 5702459 | 4 | In distribution | |
| 1002124 | In distribution | ||
| 9001020 | In distribution | ||
| 1016773 | Needle Gauge 18 G | In distribution | |
| 1048750 | 2 | In distribution | |
| 5700126 | Weight 0.2 g | In distribution | |
| 5702574 | 20 | In distribution | |
| 1005216 | In distribution | ||
| 9007012 | Weight 2 g | In distribution | |
| 9000990 | Single-Use Predosed Tips x 20 | In distribution | |
| 9007014 | Syringe Tip x 20 | In distribution | |
| 1001071 | In distribution | ||
| 1018074 | Needle Gauge 18 G | In distribution | |
| 9007015 | Syringe Tip x 20 | In distribution | |
| 5700130 | Weight 0.2 g | In distribution | |
| 1019306 | Syringe Tip x 20 | In distribution | |
| 5702581 | In distribution | ||
| 9000991 | Single-Use Predosed Tips x 20 | In distribution | |
| 1006318 | In distribution | ||
| 9001632 | In distribution | ||
| 5702458 | 4 | In distribution | |
| 9007013 | Syringe x 4 | In distribution | |
| 5702457 | 4 | In distribution | |
| 9004005 | Weight 0.3 g | In distribution | |
| 5700127 | Single Use Predosed Tips x 20 | In distribution | |
| 1003988 | Composite Catalyst | In distribution | |
| 5703018 | In distribution | ||
| 9007016 | Needle Gauge 20 G | In distribution | |
| 5702573 | 20 | In distribution | |
| 5702576 | In distribution | ||
| 5702572 | 20 | In distribution | |
| 1015337 | Weight 2 g | In distribution | |
| 5700125 | Weight 0.2 g | In distribution | |
| 9000999 | Syringe | In distribution | |
| 9004394 | 50 | In distribution | |
| 5702580 | In distribution | ||
| 5702577 | In distribution | ||
| 1069410 | Total Volume 6 ml | In distribution | |
| 1001673 | Weight 14 g | In distribution | |
| 5700123 | Single Use Predosed Tips x 20 | In distribution | |
| 1009044 | In distribution | ||
| 1013784 | Syringe x 4 | In distribution | |
| 5701369 | 50 | In distribution | |
| 5702565 | 20 | In distribution | |
| 5702984 | In distribution | ||
| 9001129 | In distribution | ||
| 5700129 | Weight 0.2 g | In distribution | |
| 5702569 | 20 | In distribution | |
| 9000993 | Single-Use Predosed Tips x 20 | In distribution | |
| 9000997 | Weight 4.5 g | In distribution | |
| 9007840 | 2 | In distribution | |
| 1005894 | In distribution | ||
| 9001319 | In distribution | ||
| 5702000 | In distribution | ||
| 9001544 | In distribution | ||
| 5702578 | In distribution | ||
| 5702455 | 4 | In distribution | |
| 1009906 | In distribution | ||
| 9000996 | Syringe | In distribution | |
| 5700134 | Weight 0.2 g | In distribution | |
| 1006047 | In distribution | ||
| 5702583 | In distribution | ||
| 9007839 | 2 | In distribution | |
| 9004395 | 50 | In distribution | |
| 1017388 | Syringe Tip x 20 | 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
Recalls
2 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 |
|---|---|---|---|---|
| 2026-07-09 | Class II | Process control | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. | 853 units |
| 2026-07-09 | Class II | Process control | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. | 121 units |
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.