Bracket, Metal, Orthodontic
50 cases Topic Roth 22,with hooks Brackets / For further information please visit our online-shop on our website www.dentaurum.de
52manufacturers in China registered for this device type
194catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K935139 |
| Record published | 2016-09-15 |
| Record revised | 2024-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2025-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 790-366-00 | 10 | In distribution | |
| 891-342-00 | In distribution | ||
| 790-344-00 | 10 | In distribution | |
| 891-344-00 | In distribution | ||
| 700-551-00 | In distribution | ||
| 891-337-00 | In distribution | ||
| 790-349-00 | 10 | In distribution | |
| 790-309-00 | 10 | In distribution | |
| 790-307-00 | 10 | In distribution | |
| 790-316-00 | 10 | In distribution | |
| 790-317-00 | 10 | In distribution | |
| 790-350-00 | 10 | In distribution | |
| 790-315-00 | 10 | In distribution | |
| 891-336-00 | In distribution | ||
| 790-342-00 | 10 | In distribution | |
| 790-314-00 | 10 | In distribution | |
| 790-319-00 | 10 | In distribution | |
| 750-603-00 | 10 | In distribution | |
| 891-339-00 | In distribution | ||
| 750-602-00 | 10 | In distribution | |
| 790-318-00 | 10 | In distribution | |
| 750-003-51 | In distribution | ||
| 700-550-00 | In distribution | ||
| 790-306-00 | 10 | In distribution | |
| 790-312-00 | 10 | In distribution | |
| 790-365-00 | 10 | In distribution | |
| 790-311-00 | 10 | In distribution | |
| 750-602-50 | 10 | In distribution | |
| 790-310-00 | 10 | In distribution | |
| 750-602-10 | 10 | In distribution | |
| 790-364-00 | 10 | In distribution | |
| 790-321-00 | 10 | In distribution | |
| 790-348-00 | 10 | In distribution | |
| 891-343-00 | In distribution | ||
| 790-302-00 | 10 | In distribution | |
| 790-351-00 | 10 | In distribution | |
| 790-343-00 | 10 | In distribution | |
| 790-346-00 | 10 | In distribution | |
| 891-333-00 | In distribution | ||
| 790-352-00 | 10 | In distribution | |
| 790-301-00 | 10 | In distribution | |
| 790-345-00 | 10 | In distribution | |
| 891-335-00 | In distribution | ||
| 891-341-00 | In distribution | ||
| 790-341-00 | 10 | In distribution | |
| 891-338-00 | In distribution | ||
| 790-304-00 | 10 | In distribution | |
| 750-001-51 | 10 | In distribution | |
| 790-313-00 | 10 | In distribution | |
| 790-322-00 | 10 | In distribution | |
| 790-363-00 | 10 | In distribution | |
| 891-340-00 | In distribution | ||
| 790-308-00 | 10 | In distribution | |
| 790-305-00 | 10 | In distribution | |
| 790-300-00 | 10 | In distribution | |
| 790-323-00 | 10 | In distribution | |
| 790-720-01 | In distribution | ||
| 750-603-10 | 10 | In distribution | |
| 790-320-00 | 10 | In distribution | |
| 891-334-00 | In distribution | ||
| 790-347-00 | 10 | In distribution | |
| 790-303-00 | 10 | In distribution | |
| 700-510-01 | Withdrawn | ||
| 784-022-00 | 10 | Withdrawn | |
| 700-509-01 | Withdrawn | ||
| 700-504-01 | Withdrawn | ||
| 700-536-01 | Withdrawn | ||
| 780-000-17 | 10 | Withdrawn | |
| 790-714-01 | Withdrawn | ||
| 700-522-01 | Withdrawn | ||
| 700-502-01 | Withdrawn | ||
| 700-519-01 | Withdrawn | ||
| 780-000-13 | 10 | Withdrawn | |
| 700-516-01 | Withdrawn | ||
| 700-512-01 | Withdrawn | ||
| 780-000-06 | 10 | Withdrawn | |
| 700-503-01 | Withdrawn | ||
| 700-531-01 | Withdrawn | ||
| 700-538-01 | Withdrawn | ||
| 790-711-01 | Withdrawn | ||
| 704-784-00 | 10 | Withdrawn | |
| 730-010-00 | 10 | Withdrawn | |
| 780-000-12 | 10 | Withdrawn | |
| 780-000-30 | 10 | Withdrawn | |
| 785-001-00 | 10 | Withdrawn | |
| 780-000-20 | 10 | Withdrawn | |
| 783-722-00 | 10 | Withdrawn | |
| 700-520-01 | Withdrawn | ||
| 700-529-01 | Withdrawn | ||
| 785-022-00 | 10 | Withdrawn | |
| 788-007-00 | 10 | Withdrawn | |
| 700-501-01 | Withdrawn | ||
| 790-721-01 | Withdrawn | ||
| 790-712-01 | Withdrawn | ||
| 700-540-01 | Withdrawn | ||
| 793-718-00 | 10 | Withdrawn | |
| 786-022-00 | 10 | Withdrawn | |
| 790-731-01 | Withdrawn | ||
| 783-018-00 | 10 | Withdrawn | |
| 790-735-01 | Withdrawn | ||
| 793-005-00 | 10 | Withdrawn | |
| 780-000-26 | 10 | Withdrawn | |
| 790-713-01 | Withdrawn | ||
| 700-521-01 | Withdrawn | ||
| 790-738-01 | Withdrawn | ||
| 700-518-01 | Withdrawn | ||
| 790-725-01 | Withdrawn | ||
| 780-000-15 | 10 | Withdrawn | |
| 700-506-01 | Withdrawn | ||
| 780-000-02 | 10 | Withdrawn | |
| 784-018-00 | 10 | Withdrawn | |
| 780-000-21 | 10 | Withdrawn | |
| 790-709-01 | Withdrawn | ||
| 790-703-01 | Withdrawn | ||
| 790-730-01 | Withdrawn | ||
| 785-002-00 | 10 | Withdrawn | |
| 790-729-01 | Withdrawn | ||
| 700-527-01 | Withdrawn | ||
| 790-727-01 | Withdrawn | ||
| 700-517-01 | Withdrawn | ||
| 790-728-01 | Withdrawn | ||
| 790-705-01 | Withdrawn | ||
| 788-022-00 | 10 | Withdrawn | |
| 780-000-18 | 10 | Withdrawn | |
| 700-530-01 | Withdrawn | ||
| 780-000-25 | 10 | Withdrawn | |
| 788-001-00 | 10 | Withdrawn | |
| 891-411-00 | 20 | Withdrawn | |
| 790-737-01 | Withdrawn | ||
| 780-000-03 | 10 | Withdrawn | |
| 700-525-01 | Withdrawn | ||
| 700-534-01 | Withdrawn | ||
| 790-715-01 | Withdrawn | ||
| 780-000-23 | 10 | Withdrawn | |
| 700-535-01 | Withdrawn | ||
| 780-000-16 | 10 | Withdrawn | |
| 790-739-01 | Withdrawn | ||
| 700-505-01 | Withdrawn | ||
| 790-716-01 | Withdrawn | ||
| 780-000-11 | 10 | Withdrawn | |
| 700-526-01 | Withdrawn | ||
| 891-410-00 | 20 | Withdrawn | |
| 790-710-01 | Withdrawn | ||
| 785-000-00 | 10 | Withdrawn | |
| 792-019-00 | 10 | Withdrawn | |
| 700-513-01 | Withdrawn | ||
| 790-707-01 | Withdrawn | ||
| 790-708-01 | Withdrawn | ||
| 790-701-01 | Withdrawn | ||
| 700-539-01 | Withdrawn | ||
| 790-724-01 | Withdrawn | ||
| 700-511-01 | Withdrawn | ||
| 780-000-31 | 10 | Withdrawn | |
| 790-732-01 | Withdrawn | ||
| 783-718-00 | 10 | Withdrawn | |
| 704-783-00 | 10 | Withdrawn | |
| 714-621-00 | 10 | Withdrawn | |
| 780-000-28 | 10 | Withdrawn | |
| 790-718-01 | Withdrawn | ||
| 790-736-01 | Withdrawn | ||
| 700-523-01 | Withdrawn | ||
| 790-740-01 | Withdrawn | ||
| 700-532-01 | Withdrawn | ||
| 790-723-01 | Withdrawn | ||
| 780-000-22 | 10 | Withdrawn | |
| 790-726-01 | Withdrawn | ||
| 790-704-01 | Withdrawn | ||
| 794-706-00 | 10 | Withdrawn | |
| 790-733-01 | Withdrawn | ||
| 780-000-10 | 10 | Withdrawn | |
| 790-722-01 | Withdrawn | ||
| 794-705-00 | 10 | Withdrawn | |
| 790-717-01 | Withdrawn | ||
| 790-719-01 | Withdrawn | ||
| 700-524-01 | Withdrawn | ||
| 780-000-29 | 10 | Withdrawn | |
| 790-706-01 | Withdrawn | ||
| 794-718-00 | 10 | Withdrawn | |
| 780-000-19 | 10 | Withdrawn | |
| 780-000-00 | 10 | Withdrawn | |
| 780-000-05 | 10 | Withdrawn | |
| 780-000-14 | 10 | Withdrawn | |
| 700-537-01 | Withdrawn | ||
| 780-000-09 | 10 | Withdrawn | |
| 700-515-01 | Withdrawn | ||
| 792-020-00 | 10 | Withdrawn | |
| 700-514-01 | Withdrawn | ||
| 700-507-01 | Withdrawn | ||
| 700-508-01 | Withdrawn | ||
| 780-000-08 | 10 | Withdrawn | |
| 700-533-01 | Withdrawn | ||
| 790-702-01 | Withdrawn | ||
| 700-528-01 | Withdrawn | ||
| 790-734-01 | Withdrawn |
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.