NuSmile BioFlx Cuspid Replacement Crown – Lower Cuspid
NuSmile BioFlx Cuspid Replacement Crown - Lower Cuspid, Size 4 - Universal / Light Shade
23manufacturers in China registered for this device type
14catalogue 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 | 2023-02-16 |
| Record revised | 2024-08-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-08-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LC4404L | In distribution | |
| LC2404L | In distribution | |
| LC1404L | In distribution | |
| LC3404L | In distribution | |
| LC5404L | In distribution | |
| LC3L404L | Withdrawn | |
| LC0R404L | Withdrawn | |
| LC6R404L | Withdrawn | |
| LC4L404L | Withdrawn | |
| LC2L404L | Withdrawn | |
| LC0L404L | Withdrawn | |
| LC1L404L | Withdrawn | |
| LC5L404L | Withdrawn | |
| LC6L404L | 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 |
| NuSmile Signature Posterior Replacement Crown | Nusmile, Ltd | 108 |
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.