NuSmile Signature Anterior Replacement Crown
NuSmile Signature Anterior Replacement Crown - Lateral, Size 2 Right - Regular Length / Extra Light Shade
23manufacturers in China registered for this device type
143catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (11), Zhejiang (3), Hong Kong (3).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Fseven Dental Technology Zhuhai Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 18 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Hangzhou DTC Medical Apparatus Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 10 |
| Joydenta Dental Laboratory | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Shenzhen Jinyi Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Zhejiang YO Medical Technology Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 10 |
Showing 12 of 23. All 23 manufacturers in China registered for Crown, Preformed
Record
| Listed by | Nusmile, Ltd, United States |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-13 |
| Record revised | 2025-11-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A6L104L | In distribution | |
| A4L104L | In distribution | |
| A2104X | In distribution | |
| B5105LS | In distribution | |
| B1L105LS | In distribution | |
| A1105XS | In distribution | |
| B4L105XS | In distribution | |
| B4R104L | In distribution | |
| A3L104L | In distribution | |
| B6L104L | In distribution | |
| B6L104X | In distribution | |
| B5105XS | In distribution | |
| A1104L | In distribution | |
| A2R105XS | In distribution | |
| A3L105LS | In distribution | |
| A2R104L | In distribution | |
| A4R105XS | In distribution | |
| A2105XS | In distribution | |
| B2105LS | In distribution | |
| B2R104X | In distribution | |
| A6105LS | In distribution | |
| A1104X | In distribution | |
| B2104X | In distribution | |
| A1105LS | In distribution | |
| B4L105LS | In distribution | |
| A6R105LS | In distribution | |
| B4104X | In distribution | |
| B6R104X | In distribution | |
| B1L104L | In distribution | |
| A4R104L | In distribution | |
| B5104L | In distribution | |
| B1104X | In distribution | |
| B5R104L | In distribution | |
| B1R104X | In distribution | |
| B2L105XS | In distribution | |
| B5L104L | In distribution | |
| A6104L | In distribution | |
| A3R104X | In distribution | |
| A6104X | In distribution | |
| B5L105XS | In distribution | |
| A2R105LS | In distribution | |
| A2104L | In distribution | |
| A5L104X | In distribution | |
| B2R105LS | In distribution | |
| A2105LS | In distribution | |
| B5R105LS | In distribution | |
| B1R105XS | In distribution | |
| B3L105LS | In distribution | |
| A1L104X | In distribution | |
| B2R105XS | In distribution | |
| A5R105XS | In distribution | |
| A3L105XS | In distribution | |
| A4L104X | In distribution | |
| B5R105XS | In distribution | |
| B3104L | In distribution | |
| B3L104L | In distribution | |
| A3L104X | In distribution | |
| B6R104L | In distribution | |
| B3105XS | In distribution | |
| B5104X | In distribution | |
| A3R105LS | In distribution | |
| B1R105LS | In distribution | |
| A1L105XS | In distribution | |
| A5R104L | In distribution | |
| A2L105XS | In distribution | |
| A4105LS | In distribution | |
| A4R104X | In distribution | |
| B4L104L | In distribution | |
| A6R104X | In distribution | |
| B4105LS | In distribution | |
| B6105LS | In distribution | |
| B3104X | In distribution | |
| A5R105LS | In distribution | |
| A3R104L | In distribution | |
| A2L104X | In distribution | |
| A4104L | In distribution | |
| B3R104L | In distribution | |
| B5L104X | In distribution | |
| B1105LS | In distribution | |
| A5L105LS | In distribution | |
| A3105XS | In distribution | |
| B2L105LS | In distribution | |
| B1105XS | In distribution | |
| A1R105XS | In distribution | |
| A3104L | In distribution | |
| A4L105XS | In distribution | |
| B3R105LS | In distribution | |
| A4L105LS | In distribution | |
| B3L105XS | In distribution | |
| B6L105LS | In distribution | |
| A6R104L | In distribution | |
| B6R105XS | In distribution | |
| B2L104L | In distribution | |
| B2L104X | In distribution | |
| B6R105LS | In distribution | |
| A4104X | In distribution | |
| B4105XS | In distribution | |
| A4R105LS | In distribution | |
| A6L105XS | In distribution | |
| A2R104X | In distribution | |
| B4L104X | In distribution | |
| B6104X | In distribution | |
| B5L105LS | In distribution | |
| A3104X | In distribution | |
| B3R104X | In distribution | |
| B1R104L | In distribution | |
| B1L105XS | In distribution | |
| A5104X | In distribution | |
| B6105XS | In distribution | |
| B1104L | In distribution | |
| A4105XS | In distribution | |
| B4R105XS | In distribution | |
| A6R105XS | In distribution | |
| B2105XS | In distribution | |
| A1R105LS | In distribution | |
| B2R104L | In distribution | |
| A3R105XS | In distribution | |
| A5L105XS | In distribution | |
| A5L104L | In distribution | |
| B4R105LS | In distribution | |
| A6L104X | In distribution | |
| A1R104X | In distribution | |
| A6L105LS | In distribution | |
| A1R104L | In distribution | |
| A2L104L | In distribution | |
| B6104L | In distribution | |
| B6L105XS | In distribution | |
| A1L105LS | In distribution | |
| A1L104L | In distribution | |
| B2104L | In distribution | |
| B1L104X | In distribution | |
| B4104L | In distribution | |
| A2L105LS | In distribution | |
| A5105LS | In distribution | |
| A3105LS | In distribution | |
| B3R105XS | In distribution | |
| A6105XS | In distribution | |
| A5104L | In distribution | |
| A5R104X | In distribution | |
| B4R104X | In distribution | |
| B5R104X | In distribution | |
| B3105LS | In distribution | |
| B3L104X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Espe™ | 3M Company | 219 |
| Directa FullForm | Directa AB | 186 |
| 3M™ Unitek™ | 3M Company | 180 |
| Directa Temporary Polycarbonate Crowns | Directa AB | 179 |
| EZCrown | Sprig Oral Health Technologies, Inc. | 157 |
| NuSmile ReVIVE Crowns | Nusmile, Ltd | 122 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 121 |
| NuSmile Pre-Contoured Stainless Steel Crown | Nusmile, Ltd | 117 |
| Bioflx Crown | Kids-E-Dental LLP | 115 |
| NuSmile ZR Posterior Replacement Crown | Nusmile, Ltd | 110 |
| NuSmile Signature Posterior Replacement Crown | Nusmile, Ltd | 108 |
| Kids-e-crown | Kids-E-Dental LLP | 106 |
Showing 12 of 372. All products under Crown, Preformed
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.