Bionic
*Bionic Bio-Pro022 UR4/5Hk OfSt Bio-Pro Rx -7° Tor 0° Ang Ofst (10PK)
52manufacturers in China registered for this device type
300catalogue 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 Technology, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2019-05-14 |
| Record revised | 2025-01-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B22-262 | In distribution | |
| B18-4300 | In distribution | |
| B22-451 | In distribution | |
| B18-752 | In distribution | |
| B22-840 | In distribution | |
| B22-4345 | In distribution | |
| BMG22-1345 | In distribution | |
| B18-771 | In distribution | |
| B22-873 | In distribution | |
| B22-832 | In distribution | |
| B22-863 | In distribution | |
| B22-869 | In distribution | |
| B222-1345 | In distribution | |
| B22-462 | In distribution | |
| B18-751 | In distribution | |
| B18-432 | In distribution | |
| B22-870 | In distribution | |
| B18-452 | In distribution | |
| B22-876 | In distribution | |
| B22-868 | In distribution | |
| B22-872 | In distribution | |
| B222-1300 | In distribution | |
| B22-818 | In distribution | |
| B18-775 | In distribution | |
| B22-826 | In distribution | |
| B22-867 | In distribution | |
| B22-864 | In distribution | |
| B22-420 | In distribution | |
| B18-762 | In distribution | |
| B18-749 | In distribution | |
| B18-431 | In distribution | |
| B18-777 | In distribution | |
| B18-769 | In distribution | |
| B18-4000 | In distribution | |
| B22-825 | In distribution | |
| B18-462 | In distribution | |
| B22-833 | In distribution | |
| B22-817 | In distribution | |
| B22-874 | In distribution | |
| B22-432 | In distribution | |
| B22-274 | In distribution | |
| B22-836 | In distribution | |
| B322-1300 | In distribution | |
| B18-732 | In distribution | |
| B18-4345 | In distribution | |
| B22-852 | In distribution | |
| BV22-300 | In distribution | |
| B22-850 | In distribution | |
| B18-735 | In distribution | |
| B22-4300 | In distribution | |
| B22-802 | In distribution | |
| B18-460 | In distribution | |
| B22-877 | In distribution | |
| BMT22-1300 | In distribution | |
| B22-440 | In distribution | |
| B18-717 | In distribution | |
| BMG18-1345 | In distribution | |
| B18-702 | In distribution | |
| B18-734 | In distribution | |
| B22-834 | In distribution | |
| B18-420 | In distribution | |
| B18-055 | In distribution | |
| B18-776 | In distribution | |
| B322-1345 | In distribution | |
| B22-801 | In distribution | |
| B18-461 | In distribution | |
| B18-733 | In distribution | |
| B18-726 | In distribution | |
| B18-422 | In distribution | |
| B22-277 | In distribution | |
| B22-233 | In distribution | |
| B18-772 | In distribution | |
| B22-851 | In distribution | |
| BMG22-1300 | In distribution | |
| B18-767 | In distribution | |
| B22-861 | In distribution | |
| B18-736 | In distribution | |
| B18-711 | In distribution | |
| B18-768 | In distribution | |
| BMG18-1300 | In distribution | |
| B22-234 | In distribution | |
| B22-422 | In distribution | |
| B18-451 | In distribution | |
| B18-450 | In distribution | |
| B22-831 | In distribution | |
| B22-812 | In distribution | |
| B22-431 | In distribution | |
| B18-774 | In distribution | |
| B18-764 | In distribution | |
| B22-460 | In distribution | |
| B18-731 | In distribution | |
| B18-400 | In distribution | |
| B22-267 | In distribution | |
| B18-761 | In distribution | |
| B22-461 | In distribution | |
| B22-835 | In distribution | |
| B18-701 | In distribution | |
| B22-878 | In distribution | |
| B22-273 | In distribution | |
| B22-849 | In distribution | |
| B18-770 | In distribution | |
| B22-875 | In distribution | |
| B18-440 | In distribution | |
| B22-410 | In distribution | |
| B22-260 | In distribution | |
| B18-712 | In distribution | |
| B18-773 | In distribution | |
| B18-410 | In distribution | |
| B22-263 | In distribution | |
| BMT18-1345 | In distribution | |
| B18-750 | In distribution | |
| B422-1300 | In distribution | |
| B22-452 | In distribution | |
| B18-421 | In distribution | |
| B18-763 | In distribution | |
| BV1822-1345 | In distribution | |
| BMT18-1300 | In distribution | |
| B18-725 | In distribution | |
| BMT22-1345 | In distribution | |
| B22-450 | In distribution | |
| B22-278 | In distribution | |
| B22-261 | In distribution | |
| B22-871 | In distribution | |
| B22-264 | In distribution | |
| B22-862 | In distribution | |
| B22-4000 | In distribution | |
| B22-400 | In distribution | |
| B18-778 | In distribution | |
| B18-430 | Withdrawn | |
| BM18-1345 | Withdrawn | |
| BM22-1300 | Withdrawn | |
| B18-053 | Withdrawn | |
| B22-237 | Withdrawn | |
| B22-061 | Withdrawn | |
| B22-232 | Withdrawn | |
| B18-074 | Withdrawn | |
| B18-062 | Withdrawn | |
| B22-222 | Withdrawn | |
| B22-534 | Withdrawn | |
| B18-061 | Withdrawn | |
| B22-238 | Withdrawn | |
| B22-023 | Withdrawn | |
| B18-562 | Withdrawn | |
| B22-523 | Withdrawn | |
| B22-270 | Withdrawn | |
| B18-553 | Withdrawn | |
| B18-566 | Withdrawn | |
| B22-501 | Withdrawn | |
| B22-566 | Withdrawn | |
| B18-072 | Withdrawn | |
| BV22-1000 | Withdrawn | |
| B22-211 | Withdrawn | |
| BM18-1000 | Withdrawn | |
| B22-070 | Withdrawn | |
| BRG22-1000 | Withdrawn | |
| BM22-1345 | Withdrawn | |
| B22-051 | Withdrawn | |
| B18-073 | Withdrawn | |
| B22-532 | Withdrawn | |
| B18-031 | Withdrawn | |
| B22-231 | Withdrawn | |
| B18-522 | Withdrawn | |
| B18-575 | Withdrawn | |
| B18-024 | Withdrawn | |
| B22-239 | Withdrawn | |
| B22-221 | Withdrawn | |
| B22-572 | Withdrawn | |
| B22-811 | Withdrawn | |
| B18-071 | Withdrawn | |
| B18-571 | Withdrawn | |
| B22-531 | Withdrawn | |
| B22-054 | Withdrawn | |
| B18-051 | Withdrawn | |
| B18-567 | Withdrawn | |
| B18-572 | Withdrawn | |
| B22-561 | Withdrawn | |
| B22-062 | Withdrawn | |
| B22-236 | Withdrawn | |
| B18-552 | Withdrawn | |
| B18-054 | Withdrawn | |
| B22-573 | Withdrawn | |
| B22-575 | Withdrawn | |
| B22-201 | Withdrawn | |
| B22-571 | Withdrawn | |
| B22-275 | Withdrawn | |
| B18-013 | Withdrawn | |
| B18-033 | Withdrawn | |
| B18-032 | Withdrawn | |
| B22-540 | Withdrawn | |
| B22-576 | Withdrawn | |
| B18-502 | Withdrawn | |
| B18-064 | Withdrawn | |
| B18-037 | Withdrawn | |
| B22-012 | Withdrawn | |
| B22-563 | Withdrawn | |
| B22-567 | Withdrawn | |
| B18-577 | Withdrawn | |
| B18-573 | Withdrawn | |
| B18-536 | Withdrawn | |
| BRG18-1300 | Withdrawn | |
| B18-540 | Withdrawn | |
| B18-040 | Withdrawn | |
| B22-271 | Withdrawn | |
| B22-535 | Withdrawn | |
| BV18-1000 | Withdrawn | |
| B18-512 | Withdrawn | |
| BV18-1345 | Withdrawn | |
| B22-071 | Withdrawn | |
| BRG22-1345 | Withdrawn | |
| B22-521 | Withdrawn | |
| B18-021 | Withdrawn | |
| BRG18-1345 | Withdrawn | |
| B22-031 | Withdrawn | |
| B22-002 | Withdrawn | |
| B22-001 | Withdrawn | |
| B22-430 | Withdrawn | |
| B18-023 | Withdrawn | |
| B22-252 | Withdrawn | |
| B18-063 | Withdrawn | |
| B22-251 | Withdrawn | |
| B22-421 | Withdrawn | |
| B18-052 | Withdrawn | |
| B18-070 | Withdrawn | |
| B22-512 | Withdrawn | |
| B18-533 | Withdrawn | |
| B18-501 | Withdrawn | |
| B22-072 | Withdrawn | |
| B22-511 | Withdrawn | |
| B22-067 | Withdrawn | |
| B22-554 | Withdrawn | |
| B18-576 | Withdrawn | |
| B22-022 | Withdrawn | |
| B18-067 | Withdrawn | |
| B18-740 | Withdrawn | |
| BV22-1345 | Withdrawn | |
| B22-552 | Withdrawn | |
| B18-511 | Withdrawn | |
| BM18-1300 | Withdrawn | |
| B22-053 | Withdrawn | |
| B22-230 | Withdrawn | |
| BV22-1300 | Withdrawn | |
| B18-563 | Withdrawn | |
| B18-565 | Withdrawn | |
| B18-718 | Withdrawn | |
| B18-012 | Withdrawn | |
| B22-240 | Withdrawn | |
| B18-022 | Withdrawn | |
| B18-561 | Withdrawn | |
| B18-034 | Withdrawn | |
| B22-524 | Withdrawn |
Showing 250 of 300 catalogue numbers.
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.