Marquis
Marquis 022 LL3 Hk Roth Rx -11° Tor. +5° Ang. (10PK)
52manufacturers in China registered for this device type
96catalogue 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 Technology, Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2019-05-02 |
| Record revised | 2025-01-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-09-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M18-030 | Withdrawn | |
| M18-021 | Withdrawn | |
| M22-060 | Withdrawn | |
| M22-070 | Withdrawn | |
| M22-022 | Withdrawn | |
| M18-071 | Withdrawn | |
| M22-011 | Withdrawn | |
| M18-001 | Withdrawn | |
| 320-22-3340 | Withdrawn | |
| 320-22-5900 | Withdrawn | |
| 320-22-4510 | Withdrawn | |
| M18-011 | Withdrawn | |
| M18-031 | Withdrawn | |
| M18-002 | Withdrawn | |
| 320-22-4350 | Withdrawn | |
| 320-22-3410 | Withdrawn | |
| 320-22-1300 | Withdrawn | |
| M22-012 | Withdrawn | |
| 320-22-4410 | Withdrawn | |
| M22-053 | Withdrawn | |
| M22-1345 | Withdrawn | |
| M18-023 | Withdrawn | |
| 320-22-3310 | Withdrawn | |
| M22-052 | Withdrawn | |
| M18-1300 | Withdrawn | |
| M22-032 | Withdrawn | |
| M22-001 | Withdrawn | |
| M22-062 | Withdrawn | |
| 320-22-2050 | Withdrawn | |
| 320-22-3350 | Withdrawn | |
| M18-024 | Withdrawn | |
| M18-440 | Withdrawn | |
| 320-22-2100 | Withdrawn | |
| 320-22-2011 | Withdrawn | |
| M18-2000 | Withdrawn | |
| M18-1345 | Withdrawn | |
| 320-22-2350 | Withdrawn | |
| M18-052 | Withdrawn | |
| M18-400 | Withdrawn | |
| M22-023 | Withdrawn | |
| M22-024 | Withdrawn | |
| M22-054 | Withdrawn | |
| 320-22-6500 | Withdrawn | |
| M22-400 | Withdrawn | |
| M22-072 | Withdrawn | |
| M18-420 | Withdrawn | |
| 320-22-6800 | Withdrawn | |
| M18-051 | Withdrawn | |
| 320-22-4310 | Withdrawn | |
| 320-22-3300 | Withdrawn | |
| M18-062 | Withdrawn | |
| 320-22-3510 | Withdrawn | |
| M22-002 | Withdrawn | |
| M18-032 | Withdrawn | |
| 320-22-4340 | Withdrawn | |
| M18-012 | Withdrawn | |
| M18-430 | Withdrawn | |
| 320-22-6400 | Withdrawn | |
| M22-410 | Withdrawn | |
| M18-410 | Withdrawn | |
| 320-22-1900 | Withdrawn | |
| M18-070 | Withdrawn | |
| M22-031 | Withdrawn | |
| 320-22-4300 | Withdrawn | |
| M22-061 | Withdrawn | |
| M18-040 | Withdrawn | |
| M22-030 | Withdrawn | |
| M18-061 | Withdrawn | |
| 320-22-1200 | Withdrawn | |
| M22-1300 | Withdrawn | |
| 320-22-2051 | Withdrawn | |
| M22-040 | Withdrawn | |
| 320-22-2310 | Withdrawn | |
| 320-22-2300 | Withdrawn | |
| M22-1000 | Withdrawn | |
| M18-022 | Withdrawn | |
| M22-021 | Withdrawn | |
| 320-22-2010 | Withdrawn | |
| 320-22-2900 | Withdrawn | |
| M18-053 | Withdrawn | |
| M18-1000 | Withdrawn | |
| M18-060 | Withdrawn | |
| M22-071 | Withdrawn | |
| 320-22-2200 | Withdrawn | |
| M22-430 | Withdrawn | |
| M22-2000 | Withdrawn | |
| 320-22-1310 | Withdrawn | |
| 320-22-1340 | Withdrawn | |
| M18-072 | Withdrawn | |
| M18-054 | Withdrawn | |
| M22-440 | Withdrawn | |
| M22-420 | Withdrawn | |
| 320-22-1100 | Withdrawn | |
| 320-22-1350 | Withdrawn | |
| 320-22-2340 | Withdrawn | |
| M22-051 | Withdrawn |
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.