H4
H4 L 1,2.021/HKS 3,4,5.022/-22 6,7 7X7 Case
52manufacturers in China registered for this device type
63catalogue 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 | World Class Technology Corporation, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-19 |
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 | Status |
|---|---|---|
| 900.2067 | In distribution | |
| 916.2006-10 | In distribution | |
| 900.2074 | In distribution | |
| 916.2024-10 | In distribution | |
| 916.2012-10 | In distribution | |
| 900.2083 | In distribution | |
| 916.2033 | In distribution | |
| 916.2011-10 | In distribution | |
| 900.2069 | In distribution | |
| 900.2073 | In distribution | |
| 900.2070 | In distribution | |
| 916.2001-10 | In distribution | |
| 916.2019-10 | In distribution | |
| 900.2075 | In distribution | |
| 900.2053 | In distribution | |
| 900.2084 | In distribution | |
| 916.2151 | In distribution | |
| 916.2007-10 | In distribution | |
| 900.2080 | In distribution | |
| 916.2017-10 | In distribution | |
| 900.2060 | In distribution | |
| 916.2010-10 | In distribution | |
| 916.2038 | In distribution | |
| 900.2035 | In distribution | |
| 900.2078 | In distribution | |
| 916.2025-10 | In distribution | |
| 916.2018-10 | In distribution | |
| 916.2034 | In distribution | |
| 900.2061 | In distribution | |
| 916.2155 | In distribution | |
| 916.2003-10 | In distribution | |
| 916.2039 | In distribution | |
| 900.2076 | In distribution | |
| 916.2008-10 | In distribution | |
| 916.2013-10 | In distribution | |
| 916.2152 | In distribution | |
| 916.2021-10 | In distribution | |
| 916.2015-10 | In distribution | |
| 916.2032 | In distribution | |
| 916.2031 | In distribution | |
| 900.2071 | In distribution | |
| 900.2034 | In distribution | |
| 916.2014-10 | In distribution | |
| 916.2020-10 | In distribution | |
| 900.1063 | In distribution | |
| 900.2087 | In distribution | |
| 900.2057 | In distribution | |
| 916.2004-10 | In distribution | |
| 900.2059 | In distribution | |
| 916.2023-10 | In distribution | |
| 900.2077 | In distribution | |
| 916.2022-10 | In distribution | |
| 916.2005-10 | In distribution | |
| 900.2082 | In distribution | |
| 916.2030 | In distribution | |
| 916.2009-10 | In distribution | |
| 900.2064 | In distribution | |
| 900.2068 | In distribution | |
| 900.2055 | In distribution | |
| 916.2016-10 | In distribution | |
| 916.2002-10 | In distribution | |
| 900.2072 | In distribution | |
| 900.2086 | 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.