Mini Twin
Roth Mini LOW Profile 018L MN 2BIC W/HK 0A (-)22T
52manufacturers in China registered for this device type
194catalogue numbers in this listing
1510(k) clearance
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 | RMO, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M13009 | 10 | In distribution | |
| M13402 | 10 | In distribution | |
| M13116 | 10 | In distribution | |
| M13424 | 10 | In distribution | |
| M13508 | 10 | In distribution | |
| M13034 | 10 | In distribution | |
| M13322 | 10 | In distribution | |
| M13029 | 10 | In distribution | |
| Mini Twin | 20 | In distribution | |
| M13433 | 10 | In distribution | |
| M13556 | 10 | In distribution | |
| M13554 | 10 | In distribution | |
| M13428 | 10 | In distribution | |
| M13560 | 10 | In distribution | |
| KM13102 | 20 | In distribution | |
| M13014 | 10 | In distribution | |
| M13510 | 10 | In distribution | |
| M13126 | 10 | In distribution | |
| M13124 | 10 | In distribution | |
| M13409 | 10 | In distribution | |
| KM13012 | 20 | In distribution | |
| M13037 | 10 | In distribution | |
| M13105 | 10 | In distribution | |
| M13113 | 10 | In distribution | |
| M13006 | 10 | In distribution | |
| M13335 | 10 | In distribution | |
| M13017 | 10 | In distribution | |
| M13131 | 10 | In distribution | |
| M13321 | 10 | In distribution | |
| M13025 | 10 | In distribution | |
| M13200 | 10 | In distribution | |
| M13026 | 10 | In distribution | |
| M13121 | 10 | In distribution | |
| M13207 | 10 | In distribution | |
| M13101 | 10 | In distribution | |
| M13132 | 10 | In distribution | |
| M13133 | 10 | In distribution | |
| M13334 | 10 | In distribution | |
| M13027 | 10 | In distribution | |
| M13226 | 10 | In distribution | |
| M13502 | 10 | In distribution | |
| M13561 | 10 | In distribution | |
| KM13502 | In distribution | ||
| M13016 | 10 | In distribution | |
| M13511 | 10 | In distribution | |
| M13313 | 10 | In distribution | |
| M13429 | 10 | In distribution | |
| M13320 | 10 | In distribution | |
| M13109 | 10 | In distribution | |
| M13557 | 10 | In distribution | |
| M13024 | 10 | In distribution | |
| M13308 | 10 | In distribution | |
| M13328 | 10 | In distribution | |
| M13304 | 10 | In distribution | |
| M13332 | 10 | In distribution | |
| M13431 | 10 | In distribution | |
| M13405 | 10 | In distribution | |
| M13435 | 10 | In distribution | |
| M13312 | 10 | In distribution | |
| M13311 | 10 | In distribution | |
| M13327 | 10 | In distribution | |
| M13035 | 10 | In distribution | |
| KM13112 | 20 | In distribution | |
| M13111 | 10 | In distribution | |
| M13430 | 10 | In distribution | |
| M13507 | 10 | In distribution | |
| M13305 | 10 | In distribution | |
| M13421 | 10 | In distribution | |
| M13013 | 10 | In distribution | |
| M13102 | 10 | In distribution | |
| M13110 | 10 | In distribution | |
| M13125 | 10 | In distribution | |
| M13300 | 10 | In distribution | |
| M13103 | 10 | In distribution | |
| M13002 | 10 | In distribution | |
| M13106 | 10 | In distribution | |
| M13408 | 10 | In distribution | |
| M13210 | 10 | In distribution | |
| M13425 | 10 | In distribution | |
| M13434 | 10 | In distribution | |
| M13427 | 10 | In distribution | |
| M13411 | 10 | In distribution | |
| M13504 | 10 | In distribution | |
| M13303 | 10 | In distribution | |
| M13011 | 10 | In distribution | |
| M13032 | 10 | In distribution | |
| M13306 | 10 | In distribution | |
| M13115 | 10 | In distribution | |
| M13231 | 10 | In distribution | |
| KM13011 | 20 | In distribution | |
| M13406 | 10 | In distribution | |
| M13137 | 10 | In distribution | |
| M13030 | 10 | In distribution | |
| M13423 | 10 | In distribution | |
| M13209 | 10 | In distribution | |
| M13201 | 10 | In distribution | |
| M13203 | 10 | In distribution | |
| M13114 | 10 | In distribution | |
| M13420 | 10 | In distribution | |
| M13552 | 10 | In distribution | |
| M13230 | 10 | In distribution | |
| KM13002 | 20 | In distribution | |
| M13403 | 10 | In distribution | |
| KM13111 | 20 | In distribution | |
| KM13202 | 20 | In distribution | |
| M13426 | 10 | In distribution | |
| M13202 | 10 | In distribution | |
| M13404 | 10 | In distribution | |
| M13333 | 10 | In distribution | |
| KM13550 | In distribution | ||
| M13008 | 10 | In distribution | |
| KM13100 | 20 | In distribution | |
| M13021 | 10 | In distribution | |
| M13323 | 10 | In distribution | |
| KM13101 | 20 | In distribution | |
| M13211 | 10 | In distribution | |
| KM13402 | In distribution | ||
| M13104 | 10 | In distribution | |
| M13506 | 10 | In distribution | |
| M13206 | 10 | In distribution | |
| M13220 | 10 | In distribution | |
| M13229 | 10 | In distribution | |
| M13023 | 10 | In distribution | |
| M13123 | 10 | In distribution | |
| M13310 | 10 | In distribution | |
| M13326 | 10 | In distribution | |
| M13422 | 10 | In distribution | |
| M13036 | 10 | In distribution | |
| M13129 | 10 | In distribution | |
| M13107 | 10 | In distribution | |
| M13301 | 10 | In distribution | |
| M13331 | 10 | In distribution | |
| M13558 | 10 | In distribution | |
| KM13302 | 20 | In distribution | |
| M13315 | 10 | In distribution | |
| M13410 | 10 | In distribution | |
| M13007 | 10 | In distribution | |
| M13020 | 10 | In distribution | |
| M13010 | 10 | In distribution | |
| M13302 | 10 | In distribution | |
| M13001 | 10 | In distribution | |
| M13003 | 10 | In distribution | |
| M13407 | 10 | In distribution | |
| M13415 | 10 | In distribution | |
| M13401 | 10 | In distribution | |
| M13413 | 10 | In distribution | |
| M13112 | 10 | In distribution | |
| M13122 | 10 | In distribution | |
| M13227 | 10 | In distribution | |
| M13019 | 10 | In distribution | |
| M13128 | 10 | In distribution | |
| M13208 | 10 | In distribution | |
| M13314 | 10 | In distribution | |
| M13135 | 10 | In distribution | |
| KM13301 | 20 | In distribution | |
| M13414 | 10 | In distribution | |
| M13012 | 10 | In distribution | |
| M13221 | 10 | In distribution | |
| M13028 | 10 | In distribution | |
| M13550 | 10 | In distribution | |
| M13100 | 10 | In distribution | |
| M13330 | 10 | In distribution | |
| M13000 | 10 | In distribution | |
| M13400 | 10 | In distribution | |
| KM13401 | 20 | In distribution | |
| M13500 | 10 | In distribution | |
| M13022 | 10 | In distribution | |
| M13127 | 10 | In distribution | |
| M13117 | 10 | In distribution | |
| M13228 | 10 | In distribution | |
| KM13500 | In distribution | ||
| M13570 | 10 | In distribution | |
| M13108 | 10 | In distribution | |
| M13033 | 10 | In distribution | |
| M13134 | 10 | In distribution | |
| M13130 | 10 | In distribution | |
| KM13001 | 20 | In distribution | |
| M13015 | 10 | In distribution | |
| M13031 | 10 | In distribution | |
| M13307 | 10 | In distribution | |
| M13412 | 10 | In distribution | |
| M13018 | 10 | In distribution | |
| M13120 | 10 | In distribution | |
| M13324 | 10 | In distribution | |
| M13329 | 10 | In distribution | |
| M13136 | 10 | In distribution | |
| KM13552 | In distribution | ||
| M13325 | 10 | In distribution | |
| M13309 | 10 | In distribution | |
| M13004 | 10 | In distribution | |
| M13520 | 10 | In distribution | |
| KM13300 | 20 | In distribution | |
| M13005 | 10 | In distribution | |
| M13432 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902050 | 1990-08-03 |
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.