Nu-Edge Bracket
LR 1st BI W/DISTAL HK VERTICAL SLOT
52manufacturers in China registered for this device type
148catalogue 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 |
|---|---|---|
| 293-166 | In distribution | |
| 293-714 | In distribution | |
| 293-085 | In distribution | |
| 293-773 | In distribution | |
| 293-015 | In distribution | |
| 293-712 | In distribution | |
| 293-831 | In distribution | |
| 293-146 | In distribution | |
| 293-7691 | In distribution | |
| 293-7591 | In distribution | |
| 293-163 | In distribution | |
| 293-764 | In distribution | |
| 293-017 | In distribution | |
| 293-730 | In distribution | |
| 293-424P | In distribution | |
| 293-011 | In distribution | |
| 293-093 | In distribution | |
| 293-111 | In distribution | |
| 293-054 | In distribution | |
| 293-1641 | In distribution | |
| 293-144 | In distribution | |
| 293-057 | In distribution | |
| 293-407 | In distribution | |
| 293-150 | In distribution | |
| 293-063 | In distribution | |
| 293-711 | In distribution | |
| 293-424P1 | In distribution | |
| 293-4211 | In distribution | |
| 293-726 | In distribution | |
| 293-758 | In distribution | |
| 293-7291 | In distribution | |
| 293-082 | In distribution | |
| 293-724 | In distribution | |
| 293-162 | In distribution | |
| 293-7681 | In distribution | |
| 293-769 | In distribution | |
| 293-725 | In distribution | |
| 293-1491 | In distribution | |
| 293-763 | In distribution | |
| 293-083 | In distribution | |
| 293-820 | In distribution | |
| 293-7231 | In distribution | |
| 293-1631 | In distribution | |
| 293-092 | In distribution | |
| 293-065 | In distribution | |
| 293-829 | In distribution | |
| 293-824 | In distribution | |
| 293-717 | In distribution | |
| 293-765 | In distribution | |
| 293-027 | In distribution | |
| 293-023 | In distribution | |
| 293-1481 | In distribution | |
| 293-754 | In distribution | |
| 293-710 | In distribution | |
| 293-061 | In distribution | |
| 293-7751 | In distribution | |
| 293-412 | In distribution | |
| 293-729 | In distribution | |
| 293-014 | In distribution | |
| 293-064 | In distribution | |
| 293-775 | In distribution | |
| 293-026 | In distribution | |
| 293-7621 | In distribution | |
| 293-161 | In distribution | |
| 293-148 | In distribution | |
| 293-716 | In distribution | |
| 293-113 | In distribution | |
| 293-062 | In distribution | |
| 293-1621 | In distribution | |
| 293-731 | In distribution | |
| 293-715 | In distribution | |
| 293-421 | In distribution | |
| 293-165 | In distribution | |
| 293-164 | In distribution | |
| 293-010 | In distribution | |
| 293-7191 | In distribution | |
| 293-021 | In distribution | |
| 293-723 | In distribution | |
| 293-1441 | In distribution | |
| 293-090 | In distribution | |
| 293-101 | In distribution | |
| 293-1131 | In distribution | |
| 293-1471 | In distribution | |
| 293-430 | In distribution | |
| 293-766 | In distribution | |
| 293-828 | In distribution | |
| 293-1661 | In distribution | |
| 293-768 | In distribution | |
| 293-056 | In distribution | |
| 293-110 | In distribution | |
| 293-718 | In distribution | |
| 293-410 | In distribution | |
| 293-772 | In distribution | |
| 293-406 | In distribution | |
| 293-060 | In distribution | |
| 293-109 | In distribution | |
| 293-827 | In distribution | |
| 293-7741 | In distribution | |
| 293-774 | In distribution | |
| 293-821 | In distribution | |
| 293-822 | In distribution | |
| 293-713 | In distribution | |
| 293-058 | In distribution | |
| 293-431 | In distribution | |
| 293-022 | In distribution | |
| 293-151 | In distribution | |
| 293-826 | In distribution | |
| 293-012 | In distribution | |
| 293-727 | In distribution | |
| 293-4101 | In distribution | |
| 293-7671 | In distribution | |
| 293-018 | In distribution | |
| 293-767 | In distribution | |
| 293-755 | In distribution | |
| 293-049 | In distribution | |
| 293-024 | In distribution | |
| 293-823 | In distribution | |
| 293-019 | In distribution | |
| 293-016 | In distribution | |
| 293-013 | In distribution | |
| 293-1111 | In distribution | |
| 293-047 | In distribution | |
| 293-059 | In distribution | |
| 293-830 | In distribution | |
| 293-427 | In distribution | |
| 293-100 | In distribution | |
| 293-099 | In distribution | |
| 293-420 | In distribution | |
| 293-722 | In distribution | |
| 293-8291 | In distribution | |
| 293-426 | In distribution | |
| 293-149 | In distribution | |
| 293-1451 | In distribution | |
| 293-025 | In distribution | |
| 293-084 | In distribution | |
| 293-720 | In distribution | |
| 293-020 | In distribution | |
| 293-4781 | In distribution | |
| 293-1651 | In distribution | |
| 293-825 | In distribution | |
| 293-478 | In distribution | |
| 293-055 | In distribution | |
| 293-762 | In distribution | |
| 293-160 | In distribution | |
| 293-728 | In distribution | |
| 293-098 | In distribution | |
| 293-052 | In distribution | |
| 293-147 | 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.