Nu-Edge Self-Ligating CoCr Brackets
UP/LO 5-5 CUS/BI W/HK W/Jigs
52manufacturers in China registered for this device type
65catalogue 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 |
|---|---|---|
| 293-317SL | In distribution | |
| 293-323SL | In distribution | |
| 293-060SL | In distribution | |
| 293-084SL | In distribution | |
| 293-294SL | In distribution | |
| 293-311SL | In distribution | |
| 293-276SL | In distribution | |
| 293-268SL | In distribution | |
| 293-011SL | In distribution | |
| 293-271SL | In distribution | |
| 293-331SL | In distribution | |
| 293-090SL | In distribution | |
| 293-015SL | In distribution | |
| 293-024SL | In distribution | |
| 293-023SL | In distribution | |
| 293-270SL | In distribution | |
| 293-107SL | In distribution | |
| 293-012SL | In distribution | |
| 293-278SL | In distribution | |
| 293-014SL | In distribution | |
| 293-333SL | In distribution | |
| 293-016SL | In distribution | |
| 293-312SL | In distribution | |
| 293-291SL | In distribution | |
| 293-322SL | In distribution | |
| 293-022SL | In distribution | |
| 293-360SL | In distribution | |
| 293-085SL | In distribution | |
| 293-316SL | In distribution | |
| 293-025SL | In distribution | |
| 293-100SL | In distribution | |
| 293-092SL | In distribution | |
| 293-362SL | In distribution | |
| 293-106SL | In distribution | |
| 293-354SL | In distribution | |
| 293-269SL | In distribution | |
| 293-059SL | In distribution | |
| 293-101SL | In distribution | |
| 293-061SL | In distribution | |
| 293-330SL | In distribution | |
| 293-058SL | In distribution | |
| 293-355SL | In distribution | |
| 293-082SL | In distribution | |
| 293-013SL | In distribution | |
| 293-279SL | In distribution | |
| 293-314SL | In distribution | |
| 293-363SL | In distribution | |
| 293-324SL | In distribution | |
| 293-294SJ | In distribution | |
| 293-083SL | In distribution | |
| 293-361SL | In distribution | |
| 293-010SL | In distribution | |
| 293-313SL | In distribution | |
| 293-098SL | In distribution | |
| 293-315SL | In distribution | |
| 293-050SL | In distribution | |
| 293-332SL | In distribution | |
| 293-277SL | In distribution | |
| 293-052SL | In distribution | |
| 293-099SL | In distribution | |
| 293-017SL | In distribution | |
| 293-310SL | In distribution | |
| 293-325SL | In distribution | |
| 293-093SL | In distribution | |
| 293-091SL | 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.