Solo Twin Bracket
.022 L4 Solo Twin Bracket Roth -17T W/HK (5)
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 | Ortho Arch Company Inc, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-06-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 462-421 | In distribution | |
| 462-501 | In distribution | |
| 462-632 | In distribution | |
| 462-512 | In distribution | |
| 462-612 | In distribution | |
| 462-445 | In distribution | |
| 462-571 | In distribution | |
| 462-602 | In distribution | |
| 462-722 | In distribution | |
| 462-601 | In distribution | |
| 462-771 | In distribution | |
| 462-661 | In distribution | |
| 462-401 | In distribution | |
| 462-562 | In distribution | |
| 462-546 | In distribution | |
| 462-412 | In distribution | |
| 462-652 | In distribution | |
| 462-431 | In distribution | |
| 462-671 | In distribution | |
| 462-772 | In distribution | |
| 462-651 | In distribution | |
| 462-746 | In distribution | |
| 462-762 | In distribution | |
| 462-672 | In distribution | |
| 462-761 | In distribution | |
| 462-452 | In distribution | |
| 462-751 | In distribution | |
| 462-662 | In distribution | |
| 462-745 | In distribution | |
| 462-561 | In distribution | |
| 462-611 | In distribution | |
| 462-712 | In distribution | |
| 462-621 | In distribution | |
| 462-702 | In distribution | |
| 462-645 | In distribution | |
| 462-721 | In distribution | |
| 462-545 | In distribution | |
| 462-521 | In distribution | |
| 462-533 | In distribution | |
| 462-731 | In distribution | |
| 462-472 | In distribution | |
| 462-462 | In distribution | |
| 462-622 | In distribution | |
| 462-546 | In distribution | |
| 462-461 | In distribution | |
| 462-502 | In distribution | |
| 462-732 | In distribution | |
| 462-411 | In distribution | |
| 462-631 | In distribution | |
| 462-471 | In distribution | |
| 462-552 | In distribution | |
| 462-446 | In distribution | |
| 462-646 | In distribution | |
| 462-432 | In distribution | |
| 462-522 | In distribution | |
| 462-531 | In distribution | |
| 462-451 | In distribution | |
| 462-511 | In distribution | |
| 462-701 | In distribution | |
| 462-402 | In distribution | |
| 462-752 | In distribution | |
| 462-422 | In distribution | |
| 462-711 | In distribution | |
| 462-563 | In distribution | |
| 462-532 | 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.