NuSmile Signature Posterior Replacement Crown
NuSmile Signature Posterior Replacement Crown - Second Primary Molar Mandibular Right, Size 4 / Extra Light Shade
23manufacturers in China registered for this device type
108catalogue 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 | 2021-09-02 |
| Record revised | 2022-01-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-01-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELL3106X | In distribution | |
| DUR7106X | In distribution | |
| DLR4106L | In distribution | |
| DLL6106L | In distribution | |
| DUL1106L | In distribution | |
| ELR4106X | In distribution | |
| EUR3106L | In distribution | |
| DUL5106L | In distribution | |
| DUR2106X | In distribution | |
| DUL3106X | In distribution | |
| DLR3106X | In distribution | |
| ELR5106L | In distribution | |
| ELR2106X | In distribution | |
| DUL2106L | In distribution | |
| EUL7106L | In distribution | |
| DLR5106L | In distribution | |
| EUR5106L | In distribution | |
| DUL7106L | In distribution | |
| DLL7106X | In distribution | |
| EUL4106L | In distribution | |
| DUR5106L | In distribution | |
| DLR3106L | In distribution | |
| DLR6106X | In distribution | |
| DLR7106L | In distribution | |
| EUL3106X | In distribution | |
| EUL1106X | In distribution | |
| EUR6106L | In distribution | |
| EUR2106L | In distribution | |
| DUL6106L | In distribution | |
| DUL4106X | In distribution | |
| DUR2106L | In distribution | |
| EUL7106X | In distribution | |
| EUL6106L | In distribution | |
| EUL4106X | In distribution | |
| DLR1106X | In distribution | |
| ELR5106X | In distribution | |
| DLL1106X | In distribution | |
| DUR3106L | In distribution | |
| DLL2106L | In distribution | |
| DUR6106X | In distribution | |
| DLL7106L | In distribution | |
| DUR4106X | In distribution | |
| ELR3106L | In distribution | |
| DLL4106X | In distribution | |
| DUR1106L | In distribution | |
| ELR6106X | In distribution | |
| ELL7106L | In distribution | |
| EUR3106X | In distribution | |
| EUR1106L | In distribution | |
| ELL2106X | In distribution | |
| DUL7106X | In distribution | |
| DLR2106X | In distribution | |
| DUR3106X | In distribution | |
| EUR5106X | In distribution | |
| DLL3106X | In distribution | |
| DLL5106L | In distribution | |
| ELR7106X | In distribution | |
| EUL5106L | In distribution | |
| EUL1106L | In distribution | |
| EUL6106X | In distribution | |
| ELR7106L | In distribution | |
| DUL1106X | In distribution | |
| DUL5106X | In distribution | |
| ELL4106L | In distribution | |
| ELR1106L | In distribution | |
| ELL1106L | In distribution | |
| ELL5106X | In distribution | |
| DLL6106X | In distribution | |
| ELL2106L | In distribution | |
| DLL5106X | In distribution | |
| ELL4106X | In distribution | |
| DLR7106X | In distribution | |
| ELR1106X | In distribution | |
| ELL7106X | In distribution | |
| ELR6106L | In distribution | |
| ELR3106X | In distribution | |
| DLR1106L | In distribution | |
| DUL4106L | In distribution | |
| DLR4106X | In distribution | |
| EUR7106X | In distribution | |
| ELL6106X | In distribution | |
| DUR7106L | In distribution | |
| ELR2106L | In distribution | |
| EUR4106X | In distribution | |
| DLR5106X | In distribution | |
| DUL2106X | In distribution | |
| DUL3106L | In distribution | |
| EUL2106X | In distribution | |
| ELL6106L | In distribution | |
| EUR2106X | In distribution | |
| EUL2106L | In distribution | |
| ELL5106L | In distribution | |
| DLL2106X | In distribution | |
| EUR4106L | In distribution | |
| DUR5106X | In distribution | |
| EUR6106X | In distribution | |
| ELL3106L | In distribution | |
| DLR6106L | In distribution | |
| DLL3106L | In distribution | |
| DLR2106L | In distribution | |
| EUL5106X | In distribution | |
| EUR7106L | In distribution | |
| DUL6106X | In distribution | |
| EUL4106L | Withdrawn | |
| EUL2106L | Withdrawn | |
| EUL3106L | Withdrawn | |
| EUL6106L | Withdrawn | |
| EUL7106L | Withdrawn |
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 Signature Anterior Replacement Crown | Nusmile, Ltd | 143 |
| 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 |
| 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.