Hu-Friedy
Lower Right Primary 1ST #3 Refill
23manufacturers in China registered for this device type
121catalogue 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 | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-20 |
| Record revised | 2021-03-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SSC-6UR7-CE | 5 | In distribution | |
| SSC-ULD2-CE | In distribution | ||
| SSC-LLD4 | In distribution | ||
| SSC-6LR5 | In distribution | ||
| SSC-LRD3-CE | In distribution | ||
| SSC-ULD3 | In distribution | ||
| SSC-6LR4 | In distribution | ||
| SSC-6UL6 | In distribution | ||
| SSC-6UR6-CE | 5 | In distribution | |
| SSC-LRE5 | In distribution | ||
| SSC-LLE6-CE | In distribution | ||
| SSC-URE5-CE | In distribution | ||
| SSC-LLD5-CE | In distribution | ||
| SSC-LRE7 | In distribution | ||
| SSC-6UL6-CE | 5 | In distribution | |
| SSC-ULD4-CE | In distribution | ||
| SSC-LRE4-CE | In distribution | ||
| SSC-6UL4 | In distribution | ||
| SSC-LLD3 | In distribution | ||
| SSC-LRD3 | In distribution | ||
| SSC-6UL4-CE | 5 | In distribution | |
| SSC-6LL6-CE | 5 | In distribution | |
| SSC-URE2 | In distribution | ||
| SSC-ULD5-CE | In distribution | ||
| SSC-LRE6-CE | In distribution | ||
| SSC-6LR2 | In distribution | ||
| SSC-URD7 | In distribution | ||
| SSC-ULD6-CE | In distribution | ||
| SSC-6UR5 | In distribution | ||
| SSC-URE6-CE | In distribution | ||
| SSC-LRD4 | In distribution | ||
| SSC-6LL5 | In distribution | ||
| SSC-6LR2-CE | 5 | In distribution | |
| SSC-LLD7-CE | In distribution | ||
| SSC-URD7-CE | In distribution | ||
| SSC-URE7 | In distribution | ||
| SSC-6UR7 | In distribution | ||
| SSC-ULD3-CE | In distribution | ||
| SSC-6LL4 | In distribution | ||
| SSC-LRD2-CE | In distribution | ||
| SSC-LLD2-CE | In distribution | ||
| SSC-6LL6 | In distribution | ||
| SSC-URE3-CE | In distribution | ||
| SSC-6UL3 | In distribution | ||
| SSC-URE2-CE | In distribution | ||
| SSC-6LR3-CE | 5 | In distribution | |
| SSC-LLE5-CE | In distribution | ||
| SSC-LLD3-CE | In distribution | ||
| SSC-6UL2 | In distribution | ||
| SSC-6UR6 | In distribution | ||
| SSC-LLE3 | In distribution | ||
| SSC-6LR3 | In distribution | ||
| SSC-6LL2 | In distribution | ||
| SSC-LRE7-CE | In distribution | ||
| SSC-URD3-CE | In distribution | ||
| SSC-LLD6-CE | In distribution | ||
| SSC-6LL4-CE | 5 | In distribution | |
| SSC-ULD7 | In distribution | ||
| SSC-6LR4-CE | 5 | In distribution | |
| SSC-6UL3-CE | 5 | In distribution | |
| SSC-LLE7-CE | In distribution | ||
| SSC-URE3 | In distribution | ||
| SSC-6LR6-CE | 5 | In distribution | |
| SSC-LLE6 | In distribution | ||
| SSC-URE4-CE | In distribution | ||
| SSC-6LR7-CE | 5 | In distribution | |
| SSC-LLD4-CE | In distribution | ||
| SSC-6UR4 | In distribution | ||
| SSC-URE5 | In distribution | ||
| SSC-URD5 | In distribution | ||
| SSC-URD6-CE | In distribution | ||
| SSC-URE6 | In distribution | ||
| SSC-ULD2 | In distribution | ||
| SSC-6LR5-CE | 5 | In distribution | |
| SSC-LLD7 | In distribution | ||
| SSC-6UL5 | In distribution | ||
| SSC-6UR3 | In distribution | ||
| SSC-URD5-CE | In distribution | ||
| SSC-6LR7 | In distribution | ||
| SSC-6LL5-CE | 5 | In distribution | |
| SSC-6UR4-CE | 5 | In distribution | |
| SSC-LLE5 | In distribution | ||
| SSC-6UR3-CE | 5 | In distribution | |
| SSC-URD3 | In distribution | ||
| SSC-6UL5-CE | 5 | In distribution | |
| SSC-ULD7-CE | In distribution | ||
| SSC-6LL2-CE | 5 | In distribution | |
| SSC-ULD5 | In distribution | ||
| SSC-LRE6 | In distribution | ||
| SSC-LLE2-CE | In distribution | ||
| SSC-6UR2-CE | 5 | In distribution | |
| SSC-URD4-CE | In distribution | ||
| SSC-LLE7 | In distribution | ||
| SSC-6LR6 | In distribution | ||
| SSC-6LL7-CE | 5 | In distribution | |
| SSC-TRAY | In distribution | ||
| SSC-LLE2 | In distribution | ||
| SSC-LLE4-CE | In distribution | ||
| SSC-6UR5-CE | 5 | In distribution | |
| SSC-6UL2-CE | 5 | In distribution | |
| SSC-ULD4 | In distribution | ||
| SSC-LLD5 | In distribution | ||
| SSC-PKIT | 24 | In distribution | |
| SSC-6UR2 | In distribution | ||
| SSC-ULD6 | In distribution | ||
| SSC-URE4 | In distribution | ||
| SSC-6LL3-CE | 5 | In distribution | |
| SSC-LLD6 | In distribution | ||
| SSC-6LL3 | In distribution | ||
| SSC-LRD2 | In distribution | ||
| SSC-PKITM | 96 | In distribution | |
| SSC-6UL7-CE | 5 | In distribution | |
| SSC-URE7-CE | In distribution | ||
| SSC-LLE4 | In distribution | ||
| SSC-LLD2 | In distribution | ||
| SSC-6UL7 | In distribution | ||
| SSC-URD4 | In distribution | ||
| SSC-URD6 | In distribution | ||
| SSC-URD2-CE | In distribution | ||
| SSC-6LL7 | In distribution | ||
| SSC-LLE3-CE | 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 Signature Anterior Replacement Crown | Nusmile, Ltd | 143 |
| NuSmile ReVIVE Crowns | Nusmile, Ltd | 122 |
| 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.