Synergy
RMO(R) Synergy(R) Bioprogressive H KIT.018 HK CUS/BIC 5-5
52manufacturers in China registered for this device type
371catalogue 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 | 2024-09-03 |
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 |
|---|---|---|---|
| KM03902 | 20 | In distribution | |
| M02636 | 10 | In distribution | |
| KM02615 | 20 | In distribution | |
| M02805 | 10 | In distribution | |
| M02302 | 10 | In distribution | |
| M02825 | 10 | In distribution | |
| M02323 | 10 | In distribution | |
| A02335 | 10 | In distribution | |
| M02202 | 10 | In distribution | |
| KM03905 | 20 | In distribution | |
| M02330 | 10 | In distribution | |
| M02831 | 10 | In distribution | |
| M02237 | 10 | In distribution | |
| M02439 | 10 | In distribution | |
| KM02303 | 20 | In distribution | |
| M02233 | 10 | In distribution | |
| M02602 | 10 | In distribution | |
| M03803 | 10 | In distribution | |
| M02864 | 10 | In distribution | |
| M07610 | 10 | In distribution | |
| M07601 | 10 | In distribution | |
| M02630 | 10 | In distribution | |
| M02659 | 10 | In distribution | |
| M02401 | 10 | In distribution | |
| A02309 | 10 | In distribution | |
| A02411 | 10 | In distribution | |
| M02802 | 10 | In distribution | |
| A02430 | 10 | In distribution | |
| M02865 | 10 | In distribution | |
| KS02615 | 20 | In distribution | |
| M02720 | 10 | In distribution | |
| M02649 | 10 | In distribution | |
| M02646 | 10 | In distribution | |
| M02429 | 10 | In distribution | |
| M02833 | 10 | In distribution | |
| M02420 | 10 | In distribution | |
| A02328 | 10 | In distribution | |
| M02612 | 10 | In distribution | |
| M02804 | 10 | In distribution | |
| KM02200 | 20 | In distribution | |
| M02604 | 10 | In distribution | |
| M02849 | 10 | In distribution | |
| M03802 | 10 | In distribution | |
| M02638 | 10 | In distribution | |
| KM02800 | 20 | In distribution | |
| M02629 | 10 | In distribution | |
| M03807 | 10 | In distribution | |
| M02665 | 10 | In distribution | |
| M02664 | 10 | In distribution | |
| M02673 | 10 | In distribution | |
| A02410 | 10 | In distribution | |
| M02732 | 10 | In distribution | |
| KM02290 | 20 | In distribution | |
| M02626 | 10 | In distribution | |
| M02614 | 10 | In distribution | |
| M02644 | 10 | In distribution | |
| M02417 | 10 | In distribution | |
| M02211 | 10 | In distribution | |
| M02662 | 10 | In distribution | |
| M03822 | 10 | In distribution | |
| KM02212 | 20 | In distribution | |
| M02711 | 10 | In distribution | |
| M02427 | 10 | In distribution | |
| M02611 | 10 | In distribution | |
| M02223 | 10 | In distribution | |
| M02750 | 10 | In distribution | |
| KM02611 | 20 | In distribution | |
| M02369 | 10 | In distribution | |
| M02320 | 10 | In distribution | |
| M02609 | 10 | In distribution | |
| KM02201 | 20 | In distribution | |
| M02339 | 10 | In distribution | |
| A02433 | 10 | In distribution | |
| A02409 | 10 | In distribution | |
| M03820 | 10 | In distribution | |
| A07502 | 20 | In distribution | |
| M02230 | 10 | In distribution | |
| M02421 | 10 | In distribution | |
| M03830 | 10 | In distribution | |
| M02304 | 10 | In distribution | |
| M03902 | 10 | In distribution | |
| A07075 | 20 | In distribution | |
| M02613 | 10 | In distribution | |
| M02801 | 10 | In distribution | |
| M02608 | 10 | In distribution | |
| A02334 | 10 | In distribution | |
| M02203 | 10 | In distribution | |
| M02374 | 10 | In distribution | |
| M02858 | 10 | In distribution | |
| M02634 | 10 | In distribution | |
| M02400 | 10 | In distribution | |
| M02700 | 10 | In distribution | |
| M07624 | 10 | In distribution | |
| M07620 | 10 | In distribution | |
| M03903 | 10 | In distribution | |
| A02332 | 10 | In distribution | |
| M02425 | 10 | In distribution | |
| M02703 | 10 | In distribution | |
| M02862 | 10 | In distribution | |
| M02348 | 10 | In distribution | |
| M02201 | 10 | In distribution | |
| M03901 | 10 | In distribution | |
| M02406 | 10 | In distribution | |
| M07606 | 10 | In distribution | |
| M02215 | 10 | In distribution | |
| M02426 | 10 | In distribution | |
| M02370 | 10 | In distribution | |
| M02473 | 10 | In distribution | |
| M02850 | 10 | In distribution | |
| KM02305 | 20 | In distribution | |
| KM03802 | 20 | In distribution | |
| M02729 | 10 | In distribution | |
| M02606 | 10 | In distribution | |
| KM02400 | 20 | In distribution | |
| M02303 | 10 | In distribution | |
| M02770 | 10 | In distribution | |
| A02333 | 10 | In distribution | |
| M08140 | 10 | In distribution | |
| KS02029 | 20 | In distribution | |
| M02331 | 10 | In distribution | |
| M02632 | 10 | In distribution | |
| M02749 | 10 | In distribution | |
| M03806 | 10 | In distribution | |
| M02620 | 10 | In distribution | |
| A07502 | 20 | In distribution | |
| M02334 | 10 | In distribution | |
| M02851 | 10 | In distribution | |
| A02435 | 10 | In distribution | |
| M03810 | 10 | In distribution | |
| M02227 | 10 | In distribution | |
| KM02702 | 20 | In distribution | |
| M02435 | 10 | In distribution | |
| M02351 | 10 | In distribution | |
| M02704 | 10 | In distribution | |
| M07604 | 10 | In distribution | |
| M02809 | 10 | In distribution | |
| A02308 | 10 | In distribution | |
| M02808 | 10 | In distribution | |
| M02322 | 10 | In distribution | |
| A02632 | 10 | In distribution | |
| M02768 | 10 | In distribution | |
| M02852 | 10 | In distribution | |
| M03900 | 10 | In distribution | |
| M02301 | 10 | In distribution | |
| M02213 | 10 | In distribution | |
| A02613 | 10 | In distribution | |
| M02424 | 10 | In distribution | |
| M02326 | 10 | In distribution | |
| M02207 | 10 | In distribution | |
| M03931 | 10 | In distribution | |
| M02316 | 10 | In distribution | |
| KM07621 | 20 | In distribution | |
| M02635 | 10 | In distribution | |
| M07630 | 10 | In distribution | |
| M02772 | 10 | In distribution | |
| M02707 | 10 | In distribution | |
| M02471 | 10 | In distribution | |
| M03938 | 10 | In distribution | |
| M02470 | 10 | In distribution | |
| A02408 | 10 | In distribution | |
| M07626 | 10 | In distribution | |
| M02645 | 10 | In distribution | |
| A02311 | 10 | In distribution | |
| M02451 | 10 | In distribution | |
| M02853 | 10 | In distribution | |
| M02407 | 10 | In distribution | |
| M02200 | 10 | In distribution | |
| M02300 | 10 | In distribution | |
| M02373 | 10 | In distribution | |
| KM07622 | 20 | In distribution | |
| M02771 | 10 | In distribution | |
| M02469 | 10 | In distribution | |
| M02432 | 10 | In distribution | |
| M02815 | 10 | In distribution | |
| M02204 | 10 | In distribution | |
| KM07690 | 20 | In distribution | |
| M02730 | 10 | In distribution | |
| M02829 | 10 | In distribution | |
| M02706 | 10 | In distribution | |
| M02615 | 10 | In distribution | |
| KM02210 | 20 | In distribution | |
| M02803 | 10 | In distribution | |
| M02411 | 10 | In distribution | |
| M07621 | 10 | In distribution | |
| M03811 | 10 | In distribution | |
| M02416 | 10 | In distribution | |
| A04159 | 20 | In distribution | |
| M02349 | 10 | In distribution | |
| M02217 | 10 | In distribution | |
| M02652 | 10 | In distribution | |
| M02605 | 10 | In distribution | |
| KM02220 | 20 | In distribution | |
| M02307 | 10 | In distribution | |
| M02672 | 10 | In distribution | |
| M02333 | 10 | In distribution | |
| KM02270 | 20 | In distribution | |
| M02631 | 10 | In distribution | |
| M02232 | 10 | In distribution | |
| M02234 | 10 | In distribution | |
| M02705 | 10 | In distribution | |
| M02800 | 10 | In distribution | |
| M02434 | 10 | In distribution | |
| M03930 | 10 | In distribution | |
| M02734 | 10 | In distribution | |
| M02637 | 10 | In distribution | |
| M02643 | 10 | In distribution | |
| M02221 | 10 | In distribution | |
| A02428 | 10 | In distribution | |
| M02639 | 10 | In distribution | |
| M02725 | 10 | In distribution | |
| M02372 | 10 | In distribution | |
| KM02380 | 20 | In distribution | |
| M02327 | 10 | In distribution | |
| M02332 | 10 | In distribution | |
| M02338 | 10 | In distribution | |
| M02654 | 10 | In distribution | |
| KM02701 | 20 | In distribution | |
| M02721 | 10 | In distribution | |
| M02653 | 10 | In distribution | |
| M02225 | 10 | In distribution | |
| A02432 | 10 | In distribution | |
| A04340 | 20 | In distribution | |
| M02206 | 10 | In distribution | |
| M02642 | 10 | In distribution | |
| KM02300 | 20 | In distribution | |
| M02855 | 10 | In distribution | |
| KM07680 | 20 | In distribution | |
| M02450 | 10 | In distribution | |
| M02601 | 10 | In distribution | |
| M02820 | 10 | In distribution | |
| M03920 | 10 | In distribution | |
| A02329 | 10 | In distribution | |
| A02428 | 10 | In distribution | |
| M02317 | 10 | In distribution | |
| M02832 | 10 | In distribution | |
| A07121 | 20 | In distribution | |
| M02408 | 10 | In distribution | |
| M02848 | 10 | In distribution | |
| A02330 | 10 | In distribution | |
| M02647 | 10 | In distribution | |
| M03801 | 10 | In distribution | |
| M02733 | 10 | In distribution | |
| M03831 | 10 | In distribution | |
| M02735 | 10 | In distribution | |
| M02627 | 10 | In distribution | |
| M02650 | 10 | In distribution | |
| KM07601 | 20 | In distribution | |
| M02859 | 10 | In distribution | |
| M02710 | 10 | In distribution | |
| M02402 | 10 | In distribution |
Showing 250 of 300 catalogue numbers.
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.