Aura
Aura Starter Medium Shade Guide KT
10manufacturers in China registered for this device type
69catalogue numbers in this listing
3510(k) clearances naming this product 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 | SDI Ltd., Australia |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer |
| Record published | 2016-09-30 |
| Record revised | 2025-01-13 (version 5) |
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 |
| Storage | Handling environment atmospheric pressure 10 to 25 °C |
| Distribution end date | 2025-01-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AURA SYR MC3 | In distribution | ||
| 8565008 | In distribution | ||
| 8565005 | In distribution | ||
| 8560011 | In distribution | ||
| 8565004 | In distribution | ||
| 8565007 | In distribution | ||
| 8560010 | In distribution | ||
| 8565002 | In distribution | ||
| AURA COMP STARTER KIT – MEDIUM | 80 | In distribution | |
| 8560009 | In distribution | ||
| AURA STARTER LIGHT SHADE GUIDE KT | 4 | In distribution | |
| AURA SYR MULTIPURPOSE KIT | 4 | In distribution | |
| AURA 20 COMP DC6 | 20 | In distribution | |
| 8560007 | In distribution | ||
| 8560005 | In distribution | ||
| AURA SYR STARTER KIT – MEDIUM | 4 | In distribution | |
| AURA 20 COMP MC5 | 20 | In distribution | |
| 8565103 | In distribution | ||
| 8565012 | In distribution | ||
| AURA COMP MULTIPURPOSE KIT | 80 | In distribution | |
| AURA 20 COMP DC7 | 20 | In distribution | |
| AURA SYR MC2 | In distribution | ||
| 8560003 | In distribution | ||
| 8565100 | In distribution | ||
| 8560006 | In distribution | ||
| 8560008 | In distribution | ||
| 8565111 | In distribution | ||
| AURA 20 COMP MC3 | 20 | In distribution | |
| 8565003 | In distribution | ||
| 8560004 | In distribution | ||
| 8560002 | In distribution | ||
| 8565001 | In distribution | ||
| AURA 20 COMP MC4 | 20 | In distribution | |
| 8565011 | In distribution | ||
| AURA MULTI CHROMA SHADE GUIDE KT | 4 | In distribution | |
| AURA SYR MC5 | In distribution | ||
| 8560012 | In distribution | ||
| 8560001 | In distribution | ||
| AURA SYR MC4 | In distribution | ||
| 8565006 | In distribution | ||
| AURA SYR STARTER KIT – LIGHT | 4 | In distribution | |
| AURA 20 COMP MC2 | 20 | In distribution | |
| 8565108 | In distribution | ||
| AURA SYR DB | Withdrawn | ||
| AURA 20 COMP DC1 | 20 | Withdrawn | |
| AURA 20 COMP E2 | 20 | Withdrawn | |
| AURA STARTER MEDIUM SHADE GUIDE KT | 4 | Withdrawn | |
| AURA COMP STARTER KIT – LIGHT | 80 | Withdrawn | |
| AURA 20 COMP BULK FILL | 20 | Withdrawn | |
| AURA 20 COMP DC3 | 20 | Withdrawn | |
| AURA 20 COMP DC4 | 20 | Withdrawn | |
| AURA SYR DC4 | Withdrawn | ||
| AURA SYR E3 | Withdrawn | ||
| AURA MASTER SHADE GUIDE KT | 12 | Withdrawn | |
| AURA SYR DC5 | Withdrawn | ||
| AURA SYR DC6 | Withdrawn | ||
| AURA SYR DC7 | Withdrawn | ||
| AURA SYR E1 | Withdrawn | ||
| AURA SYR BULK FILL | Withdrawn | ||
| AURA SYR MASTER INTRO KT | 12 | Withdrawn | |
| AURA SYR E2 | Withdrawn | ||
| AURA 20 COMP DC5 | 20 | Withdrawn | |
| AURA 20 COMP DC2 | 20 | Withdrawn | |
| AURA 20 COMP E3 | 20 | Withdrawn | |
| AURA 20 COMP DB | 20 | Withdrawn | |
| AURA SYR DC1 | Withdrawn | ||
| AURA 20 COMP E1 | 20 | Withdrawn | |
| AURA SYR DC3 | Withdrawn | ||
| AURA SYR DC2 | 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 |
|---|---|
| K222581 | 2022-10-28 |
| K222583 | 2022-10-28 |
| K102984 | 2010-12-08 |
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.