Accu Twin Bracket
.018 L5R Accu Twin Bracket Roth -22T HK (5)
52manufacturers in China registered for this device type
67catalogue 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 Arch Company Inc, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-06-14 |
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 |
|---|---|---|
| 462-071 | In distribution | |
| 462-171 | In distribution | |
| 462-351 | In distribution | |
| 462-011 | In distribution | |
| 462-032 | In distribution | |
| 462-232 | In distribution | |
| 462-331 | In distribution | |
| 462-062 | In distribution | |
| 462-121 | In distribution | |
| 462-072 | In distribution | |
| 462-262 | In distribution | |
| 462-272 | In distribution | |
| 462-312 | In distribution | |
| 462-301 | In distribution | |
| 462-051 | In distribution | |
| 462-114 | In distribution | |
| 462-131 | In distribution | |
| 462-212 | In distribution | |
| 462-145 | In distribution | |
| 462-111 | In distribution | |
| 462-002 | In distribution | |
| 462-246 | In distribution | |
| 462-122 | In distribution | |
| 462-371 | In distribution | |
| 462-211 | In distribution | |
| 462-152 | In distribution | |
| 462-001 | In distribution | |
| 462-022 | In distribution | |
| 462-112 | In distribution | |
| 462-362 | In distribution | |
| 462-372 | In distribution | |
| 462-302 | In distribution | |
| 462-061 | In distribution | |
| 462-102 | In distribution | |
| 462-245 | In distribution | |
| 462-103 | In distribution | |
| 462-221 | In distribution | |
| 462-012 | In distribution | |
| 462-162 | In distribution | |
| 462-345 | In distribution | |
| 462-311 | In distribution | |
| 462-021 | In distribution | |
| 462-202 | In distribution | |
| 462-361 | In distribution | |
| 462-113 | In distribution | |
| 462-104 | In distribution | |
| 462-346 | In distribution | |
| 462-231 | In distribution | |
| 462-046 | In distribution | |
| 462-352 | In distribution | |
| 462-161 | In distribution | |
| 462-052 | In distribution | |
| 462-222 | In distribution | |
| 462-201 | In distribution | |
| 462-252 | In distribution | |
| 462-261 | In distribution | |
| 462-146 | In distribution | |
| 462-101 | In distribution | |
| 462-311 | In distribution | |
| 462-251 | In distribution | |
| 462-332 | In distribution | |
| 462-151 | In distribution | |
| 462-031 | In distribution | |
| 462-045 | In distribution | |
| 462-271 | In distribution | |
| 462-132 | In distribution | |
| 462-322 | 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.