Bioflx Crown
Posterior Master kit "Kit - 56 Crowns First Molar : First Molar Upper Right- Sizes 1,2,3,4,5,6,7 (1 each) First Molar Upper Left- Sizes 1,2,3,4,5,6,7 (1 each) First Molar Lower Right- Sizes…
Posterior Master kit “Kit – 56 Crowns First Molar : First Molar Upper Right- Sizes 1,2,3,4,5,6,7 (1 each) First Molar Upper Left- Sizes 1,2,3,4,5,6,7 (1 each) First Molar Lower Right- Sizes 1,2,3,4,5,6,7 (1 each) First Molar Lower Left- Sizes 1,2,3,4,5,6,7 (1 each) Second Molar: Second Molar Upper Right- Sizes 1,2,3,4,5,6,7 (1 each) Second Molar Upper Left- Sizes 1,2,3,4,5,6,7 (1 each) Second Molar Lower Right- Sizes 1,2,3,4,5,6,7 (1 each) Second Molar Lower Left- Sizes 1,2,3,4,5,6,7 (1 each) “
23manufacturers in China registered for this device type
115catalogue 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 | Kids-E-Dental LLP, India |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Establishment | Specification developer, Private-label distributor, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BFX-FDUR5 | In distribution | |
| BFX-B5 | In distribution | |
| BFX-FEUR3 | In distribution | |
| BFX-PMSK | In distribution | |
| BFX-PMUL6 | In distribution | |
| BFX-FEUR6 | In distribution | |
| BFX-PMUR3 | In distribution | |
| BFX-FELR1 | In distribution | |
| BFX-FDUL7 | In distribution | |
| BFX-APK | In distribution | |
| BFX-UC2 | In distribution | |
| BFX-FDUL4 | In distribution | |
| BFX-FELR7 | In distribution | |
| BFX-B1 | In distribution | |
| BFX-FELR3 | In distribution | |
| BFX-B2 | In distribution | |
| BFX-LC2 | In distribution | |
| BFX-PMUR2 | In distribution | |
| BFX-FDLL2 | In distribution | |
| BFX-UC1 | In distribution | |
| BFX-FELR5 | In distribution | |
| BFX-FDLL4 | In distribution | |
| BFX-PMUL3 | In distribution | |
| BFX-FDLR6 | In distribution | |
| BFX-CLMK | In distribution | |
| BFX-B3 | In distribution | |
| BFX-PMLL3 | In distribution | |
| BFX-FEUR4 | In distribution | |
| BFX-PMLR6 | In distribution | |
| BFX-FELL4 | In distribution | |
| BFX-FDUL5 | In distribution | |
| BFX-A1 | In distribution | |
| BFX-FDLR2 | In distribution | |
| BFX-FDLR3 | In distribution | |
| BFX-A2 | In distribution | |
| BFX-FEUR5 | In distribution | |
| BFX-FDLR5 | In distribution | |
| BFX-FDUR7 | In distribution | |
| BFX-ASK | In distribution | |
| BFX-PMLR3 | In distribution | |
| BFX-PMUR7 | In distribution | |
| BFX-FPTK | In distribution | |
| BFX-FELR2 | In distribution | |
| BFX-PMLR5 | In distribution | |
| BFX-FEUR2 | In distribution | |
| BFX-CSK | In distribution | |
| BFX-UC3 | In distribution | |
| BFX-FDUL2 | In distribution | |
| BFX-FEUR7 | In distribution | |
| BFX-UC4 | In distribution | |
| BFX-PMLL5 | In distribution | |
| BFX-FEUL5 | In distribution | |
| BFX-AMK | In distribution | |
| BFX-B4 | In distribution | |
| BFX-CMK | In distribution | |
| BFX-FEUL7 | In distribution | |
| BFX-LC1 | In distribution | |
| BFX-LC5 | In distribution | |
| BFX-FELR6 | In distribution | |
| BFX-FDLL5 | In distribution | |
| BFX-FDLR7 | In distribution | |
| BFX-PMLR7 | In distribution | |
| BFX-CLSK | In distribution | |
| BFX-PMLL2 | In distribution | |
| BFX-FDUR3 | In distribution | |
| BFX-FDUR4 | In distribution | |
| BFX-FPMNK | In distribution | |
| BFX-PMUR4 | In distribution | |
| BFX-FDLL6 | In distribution | |
| BFX-PMLL4 | In distribution | |
| BFX-FDUL6 | In distribution | |
| BFX-FELL2 | In distribution | |
| BFX-FELL3 | In distribution | |
| BFX-FDUR1 | In distribution | |
| BFX-A3 | In distribution | |
| BFX-FEUL2 | In distribution | |
| BFX-PMLR2 | In distribution | |
| BFX-FELL1 | In distribution | |
| BFX-FDUR2 | In distribution | |
| BFX-PMUR5 | In distribution | |
| BFX-FELR4 | In distribution | |
| BFX-PMLR4 | In distribution | |
| BFX-FEUL3 | In distribution | |
| BFX-PMUL7 | In distribution | |
| BFX-FEUL4 | In distribution | |
| BFX-PMUL4 | In distribution | |
| BFX-FEUL1 | In distribution | |
| BFX-A4 | In distribution | |
| BFX-LC3 | In distribution | |
| BFX-FELL5 | In distribution | |
| BFX-FELL6 | In distribution | |
| BFX-PMLL6 | In distribution | |
| BFX-FDLL3 | In distribution | |
| BFX-FEUL6 | In distribution | |
| BFX-FDUL3 | In distribution | |
| BFX-PMMK | In distribution | |
| BFX-PMUL5 | In distribution | |
| BFX-FDLL7 | In distribution | |
| BFX-FDLR4 | In distribution | |
| BFX-FELL7 | In distribution | |
| BFX-UC5 | In distribution | |
| BFX-FPSK | In distribution | |
| BFX-LC4 | In distribution | |
| BFX-FDUR6 | In distribution | |
| BFX-FEUR1 | In distribution | |
| BFX-FDLL1 | In distribution | |
| BFX-PMLL7 | In distribution | |
| BFX-PMUR6 | In distribution | |
| BFX-FPPK | In distribution | |
| BFX-PMUL2 | In distribution | |
| BFX-FPMK | In distribution | |
| BFX-FDUL1 | In distribution | |
| BFX-FDLR1 | In distribution | |
| BFX-A5 | In distribution | |
| BFX-CLPK | 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 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 121 |
| NuSmile Pre-Contoured Stainless Steel Crown | Nusmile, Ltd | 117 |
| 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.