G&H Orthodontics ®
Auralis ROTH.018 LR3 HK -11°T 5°A 2°R 5 PK
52manufacturers in China registered for this device type
86catalogue 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 | G & H Wire Company, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-27 |
| Record revised | 2026-04-24 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 130-L4-2LK-V | 5 | In distribution | |
| 131-U1-8R-V | 5 | In distribution | |
| 130K-3-22-01 | In distribution | ||
| 130-U1-8R-V | 5 | In distribution | |
| 131-L3-2LK0-V | 5 | In distribution | |
| 131-L3-8LK0-V | 5 | In distribution | |
| 130-L4-2RK-V | 5 | In distribution | |
| 131-U2-2L-V | 5 | In distribution | |
| 130-U3-2RK-V | 5 | In distribution | |
| 131-U3-8LK-V | 5 | In distribution | |
| 130-L5-8LK-V | 5 | In distribution | |
| 131-U4-8RK-V | 5 | In distribution | |
| 130-L5-8U-V | 5 | In distribution | |
| 131-L3-8RK0-V | 5 | In distribution | |
| 131-L5-2RK-V | 5 | In distribution | |
| 131-U4-8LK-V | 5 | In distribution | |
| 130K-345-22-01 | In distribution | ||
| 130-L3-8RK-V | 5 | In distribution | |
| 130-U4-2RK-V | 5 | In distribution | |
| 130-U4-2U-V | 5 | In distribution | |
| 131-U2-8L-V | 5 | In distribution | |
| 131-L1-8U-V | 5 | In distribution | |
| 131-U3-8RK0-V | 5 | In distribution | |
| 131-L3-2RK-V | 5 | In distribution | |
| 131-U2-2R-V | 5 | In distribution | |
| 130-L4-8RK-V | 5 | In distribution | |
| 130-L3-2LK-V | 5 | In distribution | |
| 131-U3-2RK-V | 5 | In distribution | |
| 130-U2-2L-V | 5 | In distribution | |
| 130-U2-2R-V | 5 | In distribution | |
| 131-U3-2RK0-V | 5 | In distribution | |
| 130-L4-8U-V | 5 | In distribution | |
| 131-L5-8LK-V | 5 | In distribution | |
| 130-L5-8RK-V | 5 | In distribution | |
| 130-U4-8RK-V | 5 | In distribution | |
| 131-L3-2LK-V | 5 | In distribution | |
| 131-U1-2R-V | 5 | In distribution | |
| 131-U3-2LK-V | 5 | In distribution | |
| 130-L5-2RK-V | 5 | In distribution | |
| 131-U1-8L-V | 5 | In distribution | |
| 131-L5-2LK-V | 5 | In distribution | |
| 131-L4-2RK-V | 5 | In distribution | |
| 131-U4-2LK-V | 5 | In distribution | |
| 130-L5-2U-V | 5 | In distribution | |
| 131-L4-8LK-V | 5 | In distribution | |
| 131-U1-2L-V | 5 | In distribution | |
| 130-L3-2RK-V | 5 | In distribution | |
| 130-U4-8LK-V | 5 | In distribution | |
| 131K-3-18-01 | In distribution | ||
| 130-L5-2LK-V | 5 | In distribution | |
| 131-U3-8LK0-V | 5 | In distribution | |
| 130-U1-2R-V | 5 | In distribution | |
| 131-U3-2LK0-V | 5 | In distribution | |
| 130-U4-2LK-V | 5 | In distribution | |
| 131-U4-2U-V | 5 | In distribution | |
| 130-U2-8L-V | 5 | In distribution | |
| 130-L3-8LK-V | 5 | In distribution | |
| 130-U4-8U-V | 5 | In distribution | |
| 131-U2-8R-V | 5 | In distribution | |
| 131-L4-8RK-V | 5 | In distribution | |
| 131-U3-8RK-V | 5 | In distribution | |
| 130-L1-8U-V | 5 | In distribution | |
| 131-L4-2LK-V | 5 | In distribution | |
| 131-L5-8RK-V | 5 | In distribution | |
| 130-U3-2LK-V | 5 | In distribution | |
| 131-L4-2U-V | 5 | In distribution | |
| 131-U4-2RK-V | 5 | In distribution | |
| 130K-3-18-01 | In distribution | ||
| 131K-345-22-01 | In distribution | ||
| 131-L1-2U-V | 5 | In distribution | |
| 130-U3-8RK-V | 5 | In distribution | |
| 131-U4-8U-V | 5 | In distribution | |
| 131-L4-8U-V | 5 | In distribution | |
| 130K-345-18-01 | In distribution | ||
| 130-L4-2U-V | 5 | In distribution | |
| 130-L4-8LK-V | 5 | In distribution | |
| 131-L3-8LK-V | 5 | In distribution | |
| 130-U1-2L-V | 5 | In distribution | |
| 130-U3-8LK-V | 5 | In distribution | |
| 131-L3-8RK-V | 5 | In distribution | |
| 130-U1-8L-V | 5 | In distribution | |
| 131-L3-2RK0-V | 5 | In distribution | |
| 130-L1-2U-V | 5 | In distribution | |
| 131K-3-22-01 | In distribution | ||
| 130-U2-8R-V | 5 | In distribution | |
| 131K-345-18-01 | 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
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.