Synergy FX
FLI(R) Twin MBT.018 HK345 GIN 5-5 20 Bkts
52manufacturers in China registered for this device type
63catalogue 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 | 2024-08-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M04931 | 10 | In distribution | |
| M03907 | 10 | In distribution | |
| M03907 | 10 | In distribution | |
| M09530 | 10 | In distribution | |
| M04903 | 10 | In distribution | |
| M09501 | 10 | In distribution | |
| M09535 | 10 | In distribution | |
| M09600 | 10 | In distribution | |
| M09534 | 10 | In distribution | |
| M09634 | 10 | In distribution | |
| KM04902 | 20 | In distribution | |
| M04811 | 10 | In distribution | |
| M09510 | 10 | In distribution | |
| M04900 | 10 | In distribution | |
| M09601 | 10 | In distribution | |
| M09507 | 10 | In distribution | |
| M09610 | 10 | In distribution | |
| KM09602 | 20 | In distribution | |
| M09630 | 10 | In distribution | |
| KM05005 | 20 | In distribution | |
| M04926 | 10 | In distribution | |
| M09511 | 10 | In distribution | |
| M09531 | 10 | In distribution | |
| M09602 | 10 | In distribution | |
| M04807 | 10 | In distribution | |
| M04826 | 10 | In distribution | |
| M04907 | 10 | In distribution | |
| M09606 | 10 | In distribution | |
| M04920 | 10 | In distribution | |
| M09620 | 10 | In distribution | |
| M03911 | 10 | In distribution | |
| M09611 | 10 | In distribution | |
| M04810 | 10 | In distribution | |
| M04902 | 10 | In distribution | |
| M09635 | 10 | In distribution | |
| M04806 | 10 | In distribution | |
| M04820 | 10 | In distribution | |
| M09626 | 10 | In distribution | |
| M04803 | 10 | In distribution | |
| M09607 | 10 | In distribution | |
| M09526 | 10 | In distribution | |
| M04911 | 10 | In distribution | |
| M09627 | 10 | In distribution | |
| M04906 | 10 | In distribution | |
| M04930 | 10 | In distribution | |
| M03910 | 10 | In distribution | |
| M09631 | 10 | In distribution | |
| M04801 | 10 | In distribution | |
| M04800 | 10 | In distribution | |
| M09502 | 10 | In distribution | |
| M09603 | 10 | In distribution | |
| M04831 | 10 | In distribution | |
| KM04802 | 20 | In distribution | |
| M09520 | 10 | In distribution | |
| M09503 | 10 | In distribution | |
| M09506 | 10 | In distribution | |
| M04910 | 10 | In distribution | |
| KM09502 | 20 | In distribution | |
| M09500 | 10 | In distribution | |
| M04901 | 10 | In distribution | |
| M04830 | 10 | In distribution | |
| M09527 | 10 | In distribution | |
| M04802 | 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.