Straight Edge Metal Bracket
LR 2nd BI W JIGS 4.5mm Torque -22, Tip +1, Rot +4 Gingival offset 0.46mm (0.018")
52manufacturers in China registered for this device type
138catalogue 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 | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 290-614 | In distribution | |
| 292-155 | In distribution | |
| 292-152 | In distribution | |
| 292-096F | In distribution | |
| 292-156 | In distribution | |
| 292-065 | In distribution | |
| 291-612 | In distribution | |
| 292-070 | In distribution | |
| 292-163F | In distribution | |
| 292-075 | In distribution | |
| 292-153 | In distribution | |
| 292-160 | In distribution | |
| 290-606 | In distribution | |
| 292-233 | In distribution | |
| 292-159 | In distribution | |
| 292-089 | In distribution | |
| 292-088 | In distribution | |
| 290-607 | In distribution | |
| 291-601 | In distribution | |
| 292-061 | In distribution | |
| 292-102 | In distribution | |
| 291-983 | In distribution | |
| 292-177 | In distribution | |
| 292-161 | In distribution | |
| 291-976 | In distribution | |
| 292-051 | In distribution | |
| 292-062 | In distribution | |
| 290-608 | In distribution | |
| 292-094 | In distribution | |
| 292-179 | In distribution | |
| 292-097F | In distribution | |
| 292-239 | In distribution | |
| 292-095F | In distribution | |
| 292-069 | In distribution | |
| 292-175 | In distribution | |
| 291-602 | In distribution | |
| 292-068 | In distribution | |
| 291-108 | In distribution | |
| 292-183F | In distribution | |
| 292-190 | In distribution | |
| 292-097 | In distribution | |
| 290-612 | In distribution | |
| 292-076F | In distribution | |
| 292-057 | In distribution | |
| 291-107 | In distribution | |
| 290-602 | In distribution | |
| 292-220 | In distribution | |
| 291-616 | In distribution | |
| 292-237 | In distribution | |
| 291-978 | In distribution | |
| 292-181 | In distribution | |
| 292-0007 | In distribution | |
| 292-358 | In distribution | |
| 291-982 | In distribution | |
| 292-055 | In distribution | |
| 290-601 | In distribution | |
| 292-219 | In distribution | |
| 292-158 | In distribution | |
| 292-063 | In distribution | |
| 292-064 | In distribution | |
| 292-238 | In distribution | |
| 292-095 | In distribution | |
| 292-098 | In distribution | |
| 292-164 | In distribution | |
| 291-975 | In distribution | |
| 292-098F | In distribution | |
| 292-178 | In distribution | |
| 292-066 | In distribution | |
| 292-090 | In distribution | |
| 292-362 | In distribution | |
| 292-361 | In distribution | |
| 290-613 | In distribution | |
| 290-640 | In distribution | |
| 291-611 | In distribution | |
| 292-087 | In distribution | |
| 292-093 | In distribution | |
| 292-067F | In distribution | |
| 292-052 | In distribution | |
| 292-078 | In distribution | |
| 292-180 | In distribution | |
| 292-151 | In distribution | |
| 292-074 | In distribution | |
| 291-605 | In distribution | |
| 291-976F | In distribution | |
| 292-073 | In distribution | |
| 292-184F | In distribution | |
| 292-068F | In distribution | |
| 292-223 | In distribution | |
| 292-357 | In distribution | |
| 292-174 | In distribution | |
| 292-101 | In distribution | |
| 292-076 | In distribution | |
| 292-075F | In distribution | |
| 292-154 | In distribution | |
| 292-227 | In distribution | |
| 292-054 | In distribution | |
| 290-639 | In distribution | |
| 292-058 | In distribution | |
| 292-060 | In distribution | |
| 290-603 | In distribution | |
| 292-189 | In distribution | |
| 291-978F | In distribution | |
| 292-182 | In distribution | |
| 291-615 | In distribution | |
| 291-606 | In distribution | |
| 292-173 | In distribution | |
| 290-605 | In distribution | |
| 292-224 | In distribution | |
| 292-164F | In distribution | |
| 292-166 | In distribution | |
| 292-096 | In distribution | |
| 290-616 | In distribution | |
| 292-162 | In distribution | |
| 292-157 | In distribution | |
| 292-053 | In distribution | |
| 290-611 | In distribution | |
| 291-139 | In distribution | |
| 292-176 | In distribution | |
| 292-228 | In distribution | |
| 292-067 | In distribution | |
| 291-140 | In distribution | |
| 292-0008 | In distribution | |
| 291-604 | In distribution | |
| 292-081 | In distribution | |
| 292-072 | In distribution | |
| 292-071 | In distribution | |
| 292-056 | In distribution | |
| 291-603 | In distribution | |
| 292-240 | In distribution | |
| 291-979 | In distribution | |
| 290-604 | In distribution | |
| 292-059 | In distribution | |
| 292-082 | In distribution | |
| 292-234 | In distribution | |
| 292-077 | In distribution | |
| 292-163 | In distribution | |
| 290-615 | In distribution | |
| 292-165 | 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.