FLI Twin
FLI(R) Twin ROTH.022 With Hook ON Cuspid 5-5 20 Brackets
52manufacturers in China registered for this device type
186catalogue 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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M05161 | 10 | In distribution | |
| M05026 | 10 | In distribution | |
| M05011 | 10 | In distribution | |
| KM05105 | 20 | In distribution | |
| M05006 | 10 | In distribution | |
| M05065 | 10 | In distribution | |
| M05211 | 10 | In distribution | |
| M05207 | 10 | In distribution | |
| M06300 | 10 | In distribution | |
| KM05405 | 20 | In distribution | |
| M05362 | 10 | In distribution | |
| M05450 | 10 | In distribution | |
| M05125 | 10 | In distribution | |
| M05464 | 10 | In distribution | |
| M05302 | 10 | In distribution | |
| M05107 | 10 | In distribution | |
| M05032 | 10 | In distribution | |
| KM05200 | 20 | In distribution | |
| M05307 | 10 | In distribution | |
| M05329 | 10 | In distribution | |
| M05027 | 10 | In distribution | |
| M05206 | 10 | In distribution | |
| KM05401 | 20 | In distribution | |
| KM05202 | 20 | In distribution | |
| KM05100 | 20 | In distribution | |
| M05463 | 10 | In distribution | |
| KM05400 | 20 | In distribution | |
| M05363 | 10 | In distribution | |
| M05425 | 10 | In distribution | |
| M05424 | 10 | In distribution | |
| M05208 | 10 | In distribution | |
| M05205 | 10 | In distribution | |
| M05062 | 10 | In distribution | |
| M05052 | 10 | In distribution | |
| M05007 | 10 | In distribution | |
| M05310 | 10 | In distribution | |
| M05335 | 10 | In distribution | |
| M05320 | 10 | In distribution | |
| M05162 | 10 | In distribution | |
| M05364 | 10 | In distribution | |
| M05360 | 10 | In distribution | |
| M05127 | 10 | In distribution | |
| KM05101 | 20 | In distribution | |
| M05220 | 10 | In distribution | |
| M05332 | 10 | In distribution | |
| M05252 | 10 | In distribution | |
| M05420 | 10 | In distribution | |
| M05029 | 10 | In distribution | |
| M05110 | 10 | In distribution | |
| M05226 | 10 | In distribution | |
| M05124 | 10 | In distribution | |
| M05301 | 10 | In distribution | |
| M05410 | 10 | In distribution | |
| M05324 | 10 | In distribution | |
| M05405 | 10 | In distribution | |
| KM05305 | 20 | In distribution | |
| M05203 | 10 | In distribution | |
| KM05001 | 20 | In distribution | |
| M05428 | 10 | In distribution | |
| M05431 | 10 | In distribution | |
| M05404 | 10 | In distribution | |
| A04159 | 10 | In distribution | |
| M05102 | 10 | In distribution | |
| M05461 | 10 | In distribution | |
| M05227 | 10 | In distribution | |
| M05303 | 10 | In distribution | |
| M05025 | 10 | In distribution | |
| M05010 | 10 | In distribution | |
| M05163 | 10 | In distribution | |
| M05028 | 10 | In distribution | |
| M05328 | 10 | In distribution | |
| M05150 | 10 | In distribution | |
| M05365 | 10 | In distribution | |
| M05066 | 10 | In distribution | |
| M05129 | 10 | In distribution | |
| M05033 | 10 | In distribution | |
| A07075 | 10 | In distribution | |
| M05225 | 10 | In distribution | |
| M05104 | 10 | In distribution | |
| M05427 | 10 | In distribution | |
| M05411 | 10 | In distribution | |
| M05352 | 10 | In distribution | |
| M05008 | 10 | In distribution | |
| KM05402 | 20 | In distribution | |
| M05304 | 10 | In distribution | |
| M05060 | 10 | In distribution | |
| M05053 | 10 | In distribution | |
| M05311 | 10 | In distribution | |
| M05031 | 10 | In distribution | |
| M05202 | 10 | In distribution | |
| M05453 | 10 | In distribution | |
| M05408 | 10 | In distribution | |
| KS02060 | 20 | In distribution | |
| M05253 | 10 | In distribution | |
| M05435 | 10 | In distribution | |
| M05105 | 10 | In distribution | |
| M05101 | 10 | In distribution | |
| M05433 | 10 | In distribution | |
| M05361 | 10 | In distribution | |
| M05465 | 10 | In distribution | |
| M05300 | 10 | In distribution | |
| A04159 | 10 | In distribution | |
| KM05300 | 20 | In distribution | |
| M05003 | 10 | In distribution | |
| M05333 | 10 | In distribution | |
| M05366 | 10 | In distribution | |
| M05434 | 10 | In distribution | |
| M05429 | 10 | In distribution | |
| M05132 | 10 | In distribution | |
| M05153 | 10 | In distribution | |
| M05002 | 10 | In distribution | |
| M05402 | 10 | In distribution | |
| M05131 | 10 | In distribution | |
| M05330 | 10 | In distribution | |
| M05201 | 10 | In distribution | |
| M05321 | 10 | In distribution | |
| M05406 | 10 | In distribution | |
| M05325 | 10 | In distribution | |
| M05024 | 10 | In distribution | |
| M05350 | 10 | In distribution | |
| M05064 | 10 | In distribution | |
| M05426 | 10 | In distribution | |
| KM05302 | 20 | In distribution | |
| M05327 | 10 | In distribution | |
| M05035 | 10 | In distribution | |
| M05126 | 10 | In distribution | |
| M05460 | 10 | In distribution | |
| M05130 | 10 | In distribution | |
| M05106 | 10 | In distribution | |
| M05250 | 10 | In distribution | |
| M05200 | 10 | In distribution | |
| M05160 | 10 | In distribution | |
| M05353 | 10 | In distribution | |
| M05034 | 10 | In distribution | |
| M05001 | 10 | In distribution | |
| M05466 | 10 | In distribution | |
| M05166 | 10 | In distribution | |
| KM05102 | 20 | In distribution | |
| A04159 | 10 | In distribution | |
| M05103 | 10 | In distribution | |
| M06302 | 10 | In distribution | |
| M05407 | 10 | In distribution | |
| KM05000 | 20 | In distribution | |
| M05331 | 10 | In distribution | |
| M05134 | 10 | In distribution | |
| M06308 | 10 | In distribution | |
| M05004 | 10 | In distribution | |
| M05204 | 10 | In distribution | |
| M05100 | 10 | In distribution | |
| M05462 | 10 | In distribution | |
| M05030 | 10 | In distribution | |
| M05467 | 10 | In distribution | |
| M05020 | 10 | In distribution | |
| KM05301 | 20 | In distribution | |
| M05165 | 10 | In distribution | |
| M05432 | 10 | In distribution | |
| M05326 | 10 | In distribution | |
| M05224 | 10 | In distribution | |
| M05210 | 10 | In distribution | |
| M05135 | 10 | In distribution | |
| M05305 | 10 | In distribution | |
| M05005 | 10 | In distribution | |
| M05306 | 10 | In distribution | |
| M05000 | 10 | In distribution | |
| M05400 | 10 | In distribution | |
| M05067 | 10 | In distribution | |
| M05111 | 10 | In distribution | |
| M05108 | 10 | In distribution | |
| M05421 | 10 | In distribution | |
| M05063 | 10 | In distribution | |
| EJF | 10 | In distribution | |
| M05308 | 10 | In distribution | |
| M05334 | 10 | In distribution | |
| M05050 | 10 | In distribution | |
| M05167 | 10 | In distribution | |
| M05128 | 10 | In distribution | |
| KM05201 | 20 | In distribution | |
| KM05002 | 20 | In distribution | |
| M05403 | 10 | In distribution | |
| M05367 | 10 | In distribution | |
| M05164 | 10 | In distribution | |
| M05401 | 10 | In distribution | |
| M05430 | 10 | In distribution | |
| M05120 | 10 | In distribution | |
| M05452 | 10 | In distribution | |
| M05133 | 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.