Nu-Edge Metal Bracket
0.46mm (.018") CUSPID HOOK W/O VERT
52manufacturers in China registered for this device type
64catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic
Record
| Listed by | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 293-271 | In distribution | |
| 293-355 | In distribution | |
| 293-2641 | In distribution | |
| 293-358 | In distribution | |
| 293-360 | In distribution | |
| 293-365 | In distribution | |
| 293-359 | In distribution | |
| 293-373 | In distribution | |
| 293-366 | In distribution | |
| 293-2711 | In distribution | |
| 293-2731 | In distribution | |
| 293-311 | In distribution | |
| 293-386 | In distribution | |
| 293-361 | In distribution | |
| 293-371 | In distribution | |
| 293-2721 | In distribution | |
| 293-300 | In distribution | |
| 293-398 | In distribution | |
| 293-370 | In distribution | |
| 293-387 | In distribution | |
| 293-2681 | In distribution | |
| 293-354 | In distribution | |
| 293-372 | In distribution | |
| 293-369 | In distribution | |
| 293-2661 | In distribution | |
| 293-315 | In distribution | |
| 293-362 | In distribution | |
| 293-314 | In distribution | |
| 293-331 | In distribution | |
| 293-2671 | In distribution | |
| 293-317 | In distribution | |
| 293-310 | In distribution | |
| 293-2761 | In distribution | |
| 293-328 | In distribution | |
| 293-332 | In distribution | |
| 293-321 | In distribution | |
| 293-2751 | In distribution | |
| 293-323 | In distribution | |
| 293-313 | In distribution | |
| 293-378 | In distribution | |
| 293-379 | In distribution | |
| 293-363 | In distribution | |
| 293-326 | In distribution | |
| 293-316 | In distribution | |
| 293-367 | In distribution | |
| 293-357 | In distribution | |
| 293-374 | In distribution | |
| 293-376 | In distribution | |
| 293-2741 | In distribution | |
| 293-325 | In distribution | |
| 293-389 | In distribution | |
| 293-399 | In distribution | |
| 293-368 | In distribution | |
| 293-2771 | In distribution | |
| 293-388 | In distribution | |
| 293-333 | In distribution | |
| 293-324 | In distribution | |
| 293-320 | In distribution | |
| 293-2651 | In distribution | |
| 293-3661 | In distribution | |
| 293-364 | In distribution | |
| 293-375 | In distribution | |
| 293-356 | In distribution | |
| 293-312 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 2,306 |
| BioQuick® | Forestadent Bernhard Förster GmbH | 1,842 |
| Mini Master Series | American Orthodontics | 1,505 |
| Mini-Mono® | Forestadent Bernhard Förster GmbH | 1,225 |
| LP Low Profile | American Orthodontics | 1,204 |
| Mini Sprint® | Forestadent Bernhard Förster GmbH | 1,193 |
| Empower Bracket | American Orthodontics | 1,175 |
| Legend | GC Orthodontics America Inc. | 1,098 |
| Master Series | American Orthodontics | 1,084 |
| Experience® | GC Orthodontics America Inc. | 770 |
| The Orthodontic Store | Young Innovations Inc. | 658 |
| equilibrium® | Dentaurum GmbH & Co. KG | 646 |
Showing 12 of 876. All products under Bracket, Metal, Orthodontic
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.