Henry Schein
Roth Brackets .022" UL 4/5 HK -7T 0A 0O
52manufacturers in China registered for this device type
47catalogue 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 | Henry Schein, 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 | 2021-01-31 |
| Record revised | 2021-02-05 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1066834 | In distribution | ||
| 1062523 | 20 | In distribution | |
| 1068935 | 10 | In distribution | |
| 1060621 | 10 | In distribution | |
| 1060468 | 10 | In distribution | |
| 1068173 | 10 | In distribution | |
| 1069492 | 5 | In distribution | |
| 1062872 | 10 | In distribution | |
| 1065457 | 10 | In distribution | |
| 1067408 | 10 | In distribution | |
| 1062412 | 5 | In distribution | |
| 1064785 | 10 | In distribution | |
| 1065835 | 10 | In distribution | |
| 1065706 | 10 | In distribution | |
| 1067628 | In distribution | ||
| 1067066 | 10 | In distribution | |
| 1061887 | 5 | In distribution | |
| 1063647 | 10 | In distribution | |
| 1063093 | 10 | In distribution | |
| 1066085 | 10 | In distribution | |
| 1061105 | 5 | In distribution | |
| 1048346 | 21 | In distribution | |
| 1061852 | 10 | In distribution | |
| 1062309 | 10 | In distribution | |
| 1048348 | 21 | In distribution | |
| 1068135 | 10 | In distribution | |
| 1066684 | In distribution | ||
| 1067957 | 10 | In distribution | |
| 1067216 | 5 | In distribution | |
| 1066019 | 10 | In distribution | |
| 1068317 | 10 | In distribution | |
| 1061141 | 10 | In distribution | |
| 1062523 | 20 | In distribution | |
| 1069821 | 10 | In distribution | |
| 1063988 | 10 | In distribution | |
| 1066684 | In distribution | ||
| 1069882 | 5 | In distribution | |
| 1062794 | 10 | In distribution | |
| 1060927 | 5 | In distribution | |
| 1066716 | 10 | In distribution | |
| 1068160 | 10 | In distribution | |
| 1061683 | 10 | In distribution | |
| 1061045 | 10 | In distribution | |
| 1066088 | 10 | In distribution | |
| 1064231 | 20 | In distribution | |
| 1065033 | 10 | In distribution | |
| 1063397 | 10 | 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.