Safco Polycarbonate Crowns
Safco polycarbonate crowns #101 upper right central 5/box
23manufacturers in China registered for this device type
98catalogue 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 | Safco Dental Supply, United States |
|---|---|
| FDA product code | ELZ |
| Device type | Crown, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3330 |
| Premarket notification | Exempt |
| Record published | 2021-05-14 |
| Record revised | 2021-08-11 (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 |
|---|---|---|---|
| 1022226 | 5 | In distribution | |
| 1022313 | 5 | In distribution | |
| 1022140 | 5 | In distribution | |
| 1022306 | 5 | In distribution | |
| 1026568 | 5 | In distribution | |
| 1022355 | 5 | In distribution | |
| 1026539 | 5 | In distribution | |
| 1022109 | 5 | In distribution | |
| 1026532 | 5 | In distribution | |
| 1022261 | 5 | In distribution | |
| 1022379 | 5 | In distribution | |
| 1026535 | 5 | In distribution | |
| 1022328 | 5 | In distribution | |
| 1022011 | 150 | In distribution | |
| 1026503 | 5 | In distribution | |
| 1026559 | 5 | In distribution | |
| 1022388 | 5 | In distribution | |
| 1022257 | 5 | In distribution | |
| 1022151 | 5 | In distribution | |
| 1022148 | 5 | In distribution | |
| 1022167 | 5 | In distribution | |
| 1022362 | 5 | In distribution | |
| 1022195 | 5 | In distribution | |
| 1026514 | 5 | In distribution | |
| 1022186 | 5 | In distribution | |
| 1022179 | 5 | In distribution | |
| 1022200 | 5 | In distribution | |
| 1022111 | 5 | In distribution | |
| 1026594 | 5 | In distribution | |
| 1022182 | 5 | In distribution | |
| 1022344 | 5 | In distribution | |
| 1022273 | 5 | In distribution | |
| 1022284 | 5 | In distribution | |
| 1026519 | 5 | In distribution | |
| 1022223 | 5 | In distribution | |
| 1022204 | 5 | In distribution | |
| 1022104 | 5 | In distribution | |
| 1022397 | 5 | In distribution | |
| 1022235 | 5 | In distribution | |
| 1022390 | 5 | In distribution | |
| 1026584 | 5 | In distribution | |
| 1026592 | 5 | In distribution | |
| 1022373 | 5 | In distribution | |
| 1022095 | 160 | In distribution | |
| 1022366 | 5 | In distribution | |
| 1022289 | 5 | In distribution | |
| 1026577 | 5 | In distribution | |
| 1026506 | 5 | In distribution | |
| 1022073 | 40 | In distribution | |
| 1022278 | 5 | In distribution | |
| 1026556 | 5 | In distribution | |
| 1022117 | 5 | In distribution | |
| 1022239 | 5 | In distribution | |
| 1022339 | 5 | In distribution | |
| 1026526 | 5 | In distribution | |
| 1022265 | 5 | In distribution | |
| 1026523 | 5 | In distribution | |
| 1026516 | 5 | In distribution | |
| 1026570 | 5 | In distribution | |
| 1022125 | 5 | In distribution | |
| 1022321 | 5 | In distribution | |
| 1022120 | 1,022,120 | In distribution | |
| 1026574 | 5 | In distribution | |
| 1026553 | 5 | In distribution | |
| 1026580 | 5 | In distribution | |
| 1022375 | 5 | In distribution | |
| 1022056 | 120 | In distribution | |
| 1022042 | 70 | In distribution | |
| 1022351 | 5 | In distribution | |
| 1022136 | 5 | In distribution | |
| 1022163 | 5 | In distribution | |
| 1026544 | 5 | In distribution | |
| 1022217 | 5 | In distribution | |
| 1026529 | 5 | In distribution | |
| 1022241 | 5 | In distribution | |
| 1026587 | 5 | In distribution | |
| 1026541 | 5 | In distribution | |
| 1022212 | 5 | In distribution | |
| 1026512 | 5 | In distribution | |
| 1022332 | 5 | In distribution | |
| 1022296 | 5 | In distribution | |
| 1022252 | 5 | In distribution | |
| 1026550 | 5 | In distribution | |
| 1022300 | 5 | In distribution | |
| 1022132 | 5 | In distribution | |
| 1026521 | 5 | In distribution | |
| 1022290 | 5 | In distribution | |
| 1022027 | 120 | In distribution | |
| 1026509 | 5 | In distribution | |
| 1022384 | 5 | In distribution | |
| 1026564 | 5 | In distribution | |
| 1022248 | 5 | In distribution | |
| 1026547 | 5 | In distribution | |
| 1022317 | 5 | In distribution | |
| 1026562 | 5 | In distribution | |
| 1022199 | 5 | In distribution | |
| 1022347 | 5 | In distribution | |
| 1022174 | 5 | 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 |
| 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.