Wave
Wave MV 1 SYR A3.5
10manufacturers in China registered for this device type
78catalogue 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 |
| 510(k) | K973091 |
| Record published | 2025-01-08 |
| Record revised | 2025-01-13 (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, manufacturing date |
| Storage | Special storage condition: Storage conditions 10°C – 25°C (50 – 77°F) Recommended Cool Room Storage Do not refrigerate SDI composite products. |
| Distribution end date | 2025-01-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7514147 | In distribution | ||
| 7512324 | In distribution | ||
| 8311101 | In distribution | ||
| 7512223 | In distribution | ||
| 8310405 | In distribution | ||
| 7520003 | In distribution | ||
| 7510405 | In distribution | ||
| 7500000 | In distribution | ||
| 8211101 | In distribution | ||
| WAVE MV 20 COMP A1 | 20 | In distribution | |
| 7511101 | In distribution | ||
| 8310204 | In distribution | ||
| 7510102 | In distribution | ||
| WAVE MV 1 SYR B2 | In distribution | ||
| 7514143 | In distribution | ||
| 8300000 | In distribution | ||
| WAVE HV 1 SYR B2 | In distribution | ||
| 8320002 | In distribution | ||
| 8210102 | In distribution | ||
| 8210405 | In distribution | ||
| 8210304 | In distribution | ||
| WAVE HV 1 SYR OA2 | In distribution | ||
| 8210203 | In distribution | ||
| 7513334 | In distribution | ||
| 7520003 | In distribution | ||
| 7511211 | In distribution | ||
| 7500013 | In distribution | ||
| 7500011 | In distribution | ||
| 7510204 | In distribution | ||
| WAVE MV 1 SYR C2 | In distribution | ||
| WAVE 20 COMP A3.5 | 20 | In distribution | |
| 8310203 | In distribution | ||
| 7500012 | In distribution | ||
| 7510304 | In distribution | ||
| WAVE HV INTRO KT | 4 | In distribution | |
| 7520001 | In distribution | ||
| WAVE HV 1 SYR B | In distribution | ||
| 7511314 | In distribution | ||
| WAVE 1 SYR I | In distribution | ||
| WAVE HV 1 SYR C2 | In distribution | ||
| 8310102 | In distribution | ||
| 7510203 | In distribution | ||
| 8311101 | In distribution | ||
| WAVE 1 SYR A1 | Withdrawn | ||
| WAVE MV 1 SYR OA2 | Withdrawn | ||
| WAVE HV 1 SYR A1 | Withdrawn | ||
| WAVE 1 SYR A3 | Withdrawn | ||
| WAVE 1 SYR D3 | Withdrawn | ||
| WAVE 1 SYR OA2 | Withdrawn | ||
| WAVE 1 SYR B1 | Withdrawn | ||
| WAVE HV 1 SYR A3.5 | Withdrawn | ||
| WAVE BULK KT A3 | 10 | Withdrawn | |
| WAVE 1 SYR A3.5 | Withdrawn | ||
| WAVE MV 1 SYR A1 | Withdrawn | ||
| WAVE MV 20 COMP A2 | 20 | Withdrawn | |
| WAVE INTRO KT | 4 | Withdrawn | |
| WAVE HV 1 SYR A2 | Withdrawn | ||
| WAVE BULK KT A1 | 10 | Withdrawn | |
| WAVE MV 1 SYR B1 | Withdrawn | ||
| WAVE 1 SYR C2 | Withdrawn | ||
| WAVE MV 20 COMP A3 | 20 | Withdrawn | |
| WAVE HV 1 SYR A3 | Withdrawn | ||
| WAVE 1 SYR B3 | Withdrawn | ||
| WAVE MV 1 SYR A3.5 | Withdrawn | ||
| WAVE 1 SYR G | Withdrawn | ||
| WAVE BULK KT A2 | 10 | Withdrawn | |
| WAVE 1 SYR C3 | Withdrawn | ||
| WAVE 20 COMP A2 | 20 | Withdrawn | |
| WAVE MV 1 SYR B | Withdrawn | ||
| WAVE 1 SYR A2 | Withdrawn | ||
| WAVE MV 1 SYR A2 | Withdrawn | ||
| WAVE MV INTRO KT | 4 | Withdrawn | |
| WAVE MV 1 SYR A3 | Withdrawn | ||
| WAVE 20 COMP A1 | 20 | Withdrawn | |
| WAVE 1 SYR B2 | Withdrawn | ||
| WAVE HV 1 SYR B1 | Withdrawn | ||
| WAVE 1 SYR B | Withdrawn | ||
| WAVE 20 COMP A3 | 20 | 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.