Leone SPA
Alexander DB Brackets 22 Midi Diag Kitdb Brackets 21 Midi Diag 22 T+14 A+5
52manufacturers in China registered for this device type
2,306catalogue 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 | Leone SPA, Italy |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-18 |
| Record revised | 2021-12-08 (version 3) |
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 |
|---|---|---|
| F1102-32 | In distribution | |
| F1000-41 | In distribution | |
| F4415-91 | In distribution | |
| F4020-11 | In distribution | |
| F4520-42 | In distribution | |
| F2171-91 | In distribution | |
| F2485-906 | In distribution | |
| F6122-944 | In distribution | |
| G2089-914 | In distribution | |
| F4220-932 | In distribution | |
| F4580-94 | In distribution | |
| F2020B11 | In distribution | |
| F2023S04 | In distribution | |
| F7210-91 | In distribution | |
| F7183-03 | In distribution | |
| F2483-923 | In distribution | |
| F7310-925 | In distribution | |
| F9280-942 | In distribution | |
| F4375-03 | In distribution | |
| F2180N05 | In distribution | |
| F4580-944 | In distribution | |
| F7380-924 | In distribution | |
| F2289-904 | In distribution | |
| F6122-912 | In distribution | |
| F9280-44 | In distribution | |
| F4420-924 | In distribution | |
| F2413-917 | In distribution | |
| F2623-03 | In distribution | |
| F9220-932 | In distribution | |
| F9220-931 | In distribution | |
| F7170-91 | In distribution | |
| F4520-914 | In distribution | |
| F4470-933 | In distribution | |
| F2482-902 | In distribution | |
| F2280-905 | In distribution | |
| F4420-941 | In distribution | |
| F6319-45 | In distribution | |
| F4410-943 | In distribution | |
| F2479W06 | In distribution | |
| F2410J93 | In distribution | |
| F2473S07 | In distribution | |
| F2489T25 | In distribution | |
| F7375-91 | In distribution | |
| F2419W16 | In distribution | |
| F2079-902 | In distribution | |
| F2129G04 | In distribution | |
| F7213-906 | In distribution | |
| F7124C906 | In distribution | |
| F2180Q05 | In distribution | |
| F1000-14 | In distribution | |
| F2113S02 | In distribution | |
| F7073-02 | In distribution | |
| F7121-03 | In distribution | |
| F4210-91Z | In distribution | |
| F6120-92 | In distribution | |
| F4210-934 | In distribution | |
| F7310-33 | In distribution | |
| F4275-902 | In distribution | |
| F4480-933 | In distribution | |
| F4580-911 | In distribution | |
| F6122-941 | In distribution | |
| F6221-931 | In distribution | |
| F2121J95 | In distribution | |
| F7282-903 | In distribution | |
| F7082C907 | In distribution | |
| F4274-03 | In distribution | |
| F4211-35 | In distribution | |
| F2089X04 | In distribution | |
| F9020-92 | In distribution | |
| F2082C21 | In distribution | |
| F4382-03 | In distribution | |
| F7125C902 | In distribution | |
| F6380-31 | In distribution | |
| F2026-14 | In distribution | |
| F2485-94 | In distribution | |
| F7380-933 | In distribution | |
| F7125-906 | In distribution | |
| F6114-23 | In distribution | |
| F4480-31 | In distribution | |
| F2115-95 | In distribution | |
| F4381-03 | In distribution | |
| F6122-34 | In distribution | |
| F7179-903 | In distribution | |
| F2123-95 | In distribution | |
| F2473F23 | In distribution | |
| F7179-902 | In distribution | |
| F2085-91 | In distribution | |
| F7273C907 | In distribution | |
| F4420-42 | In distribution | |
| F4270-944 | In distribution | |
| G2028-04 | In distribution | |
| F4215-91 | In distribution | |
| F2485-92 | In distribution | |
| F4385-902 | In distribution | |
| F6123-91 | In distribution | |
| F6122-45 | In distribution | |
| F7084-903 | In distribution | |
| F4420-914 | In distribution | |
| F4270-44 | In distribution | |
| F2471J93 | In distribution | |
| F2083S24 | In distribution | |
| X0008 | In distribution | |
| F4520-31 | In distribution | |
| F4210-92Z | In distribution | |
| F4420-11 | In distribution | |
| F4210-923 | In distribution | |
| F9220-11 | In distribution | |
| F4374-903 | In distribution | |
| G2080-904 | In distribution | |
| F2220-91 | In distribution | |
| F4410-945 | In distribution | |
| F4213-906 | In distribution | |
| F2485X07 | In distribution | |
| F4381-02 | In distribution | |
| F7380-44 | In distribution | |
| F4480-24 | In distribution | |
| F2473F13 | In distribution | |
| F2482-933 | In distribution | |
| F1001-91 | In distribution | |
| F2089-904 | In distribution | |
| F4520-14 | In distribution | |
| F4580-945 | In distribution | |
| F2080O35 | In distribution | |
| F2129X04 | In distribution | |
| F4285-02 | In distribution | |
| F7222-903 | In distribution | |
| F2070-91 | In distribution | |
| F4420-43 | In distribution | |
| F9220-942 | In distribution | |
| F7380-932 | In distribution | |
| F4420-912 | In distribution | |
| F1002-31 | In distribution | |
| F2082C31 | In distribution | |
| F2089T14 | In distribution | |
| F2081-921 | In distribution | |
| F6212-935 | In distribution | |
| G2080-44 | In distribution | |
| G2890-00 | In distribution | |
| F1000-23 | In distribution | |
| F7370-35 | In distribution | |
| F6319-35 | In distribution | |
| F4410-43 | In distribution | |
| F4383-907 | In distribution | |
| F2421-13 | In distribution | |
| F4211-25 | In distribution | |
| F7283C907 | In distribution | |
| G2020-914 | In distribution | |
| F4214-02 | In distribution | |
| F7082-02 | In distribution | |
| F4410C945 | In distribution | |
| F7274-907 | In distribution | |
| F4270-933 | In distribution | |
| F2419-917 | In distribution | |
| F2029K04 | In distribution | |
| F4410-91 | In distribution | |
| F2429H11 | In distribution | |
| F4215-902 | In distribution | |
| F4470-944 | In distribution | |
| F2482-42 | In distribution | |
| F4520-41 | In distribution | |
| F6212-43 | In distribution | |
| F7320-43 | In distribution | |
| F4284-03 | In distribution | |
| F7221-03 | In distribution | |
| F2022-31 | In distribution | |
| F1100-11 | In distribution | |
| F2489-15 | In distribution | |
| F7380-912 | In distribution | |
| F4984-04 | In distribution | |
| G2086-914 | In distribution | |
| F7310-34 | In distribution | |
| F2481-922 | In distribution | |
| F4420-33 | In distribution | |
| F7283C902 | In distribution | |
| G2489-01 | In distribution | |
| F2080N35 | In distribution | |
| F4373-91 | In distribution | |
| F1001-92 | In distribution | |
| F7370-25 | In distribution | |
| F4373-907 | In distribution | |
| F7370-924 | In distribution | |
| F2029I04 | In distribution | |
| F4275-06 | In distribution | |
| F4383-906 | In distribution | |
| F6221-31 | In distribution | |
| F9088-14 | In distribution | |
| F4270-943 | In distribution | |
| F9210-935 | In distribution | |
| F4210-924 | In distribution | |
| F7370-923 | In distribution | |
| F6374-23 | In distribution | |
| F2481-23 | In distribution | |
| F7119-902 | In distribution | |
| F2123-04 | In distribution | |
| G2824-00 | In distribution | |
| F6212-35 | In distribution | |
| G2020-44 | In distribution | |
| F7380-943 | In distribution | |
| F6379-14 | In distribution | |
| F2483-92 | In distribution | |
| G2086-14 | In distribution | |
| F1000-22 | In distribution | |
| F2123-02 | In distribution | |
| F4410-14 | In distribution | |
| F4225-03 | In distribution | |
| F7320-945 | In distribution | |
| F2483-903 | In distribution | |
| F6122-21 | In distribution | |
| F6319-34 | In distribution | |
| F9220-935 | In distribution | |
| F7082C902 | In distribution | |
| F2113-95 | In distribution | |
| F4225-906 | In distribution | |
| X0029 | In distribution | |
| F4280-31 | In distribution | |
| F2080-91 | In distribution | |
| F4410C925 | In distribution | |
| F7273-07 | In distribution | |
| F2421-912 | In distribution | |
| F2225-91 | In distribution | |
| F6113-15 | In distribution | |
| F4580-24 | In distribution | |
| F2423F43 | In distribution | |
| F2080-915 | In distribution | |
| F7221-02 | In distribution | |
| F7083C903 | In distribution | |
| F2489-925 | In distribution | |
| F7111-91 | In distribution | |
| F9280-922 | In distribution | |
| G2423-16 | In distribution | |
| F7283-03 | In distribution | |
| F7370-934 | In distribution | |
| F2019-902 | In distribution | |
| F7184-02 | In distribution | |
| F7310-14 | In distribution | |
| F7281-03 | In distribution | |
| G2429-15 | In distribution | |
| F4520-943 | In distribution | |
| F7173-07 | In distribution | |
| F2129T04 | In distribution | |
| F7185C902 | In distribution | |
| F2075-03 | In distribution | |
| F4215-906 | In distribution | |
| F4283-06 | In distribution | |
| F4211-13 | In distribution | |
| F9210-43 | In distribution | |
| F2089I14 | In distribution | |
| F4420-942 | In distribution | |
| F4280-942 | In distribution | |
| F6320-11 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Stainless Steel Brackets | American Orthodontics | 612 |
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.