Avex CX
Avex CX .018 Kit 5 X 5 U & L Hooks 3, 4, 5
52manufacturers in China registered for this device type
80catalogue numbers in this listing
1recall
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 | Ultradent Products Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 225003 | Slot Width.022 in | In distribution |
| 224014 | Slot Width.022 in | In distribution |
| 214010 | Slot Width.018 in | In distribution |
| 224058 | Slot Width.022 in | In distribution |
| 214002 | Slot Width.018 in | In distribution |
| 214034 | Slot Width.018 in | In distribution |
| 224040 | Slot Width.022 in | In distribution |
| 214018 | Slot Width.018 in | In distribution |
| 224046 | Slot Width.022 in | In distribution |
| 214006 | Slot Width.018 in | In distribution |
| 224026 | Slot Width.022 in | In distribution |
| 214009 | Slot Width.018 in | In distribution |
| 214004 | Slot Width.018 in | In distribution |
| 224044 | Slot Width.022 in | In distribution |
| 214038 | Slot Width.018 in | In distribution |
| 224029 | Slot Width.022 in | In distribution |
| 214050 | Slot Width.018 in | In distribution |
| 214012 | Slot Width.018 in | In distribution |
| 214040 | Slot Width.018 in | In distribution |
| 214054 | Slot Width.018 in | In distribution |
| 214031 | Slot Width.018 in | In distribution |
| 215004 | Slot Width.018 in | In distribution |
| 224011 | Slot Width.022 in | In distribution |
| 224027 | Slot Width.022 in | In distribution |
| 214015 | Slot Width.018 in | In distribution |
| 224047 | Slot Width.022 in | In distribution |
| 225005 | Slot Width.022 in | In distribution |
| 224016 | Slot Width.022 in | In distribution |
| 224017 | Slot Width.022 in | In distribution |
| 224043 | Slot Width.022 in | In distribution |
| 224033 | Slot Width.022 in | In distribution |
| 214011 | Slot Width.018 in | In distribution |
| 214001 | Slot Width.018 in | In distribution |
| 214003 | Slot Width.018 in | In distribution |
| 214039 | Slot Width.018 in | In distribution |
| 214016 | Slot Width.018 in | In distribution |
| 214029 | Slot Width.018 in | In distribution |
| 224009 | Slot Width.022 in | In distribution |
| 224039 | Slot Width.022 in | In distribution |
| 224005 | Slot Width.022 in | In distribution |
| 225001 | Slot Width.022 in | In distribution |
| 224018 | Slot Width.022 in | In distribution |
| 214017 | Slot Width.018 in | In distribution |
| 215001 | Slot Width.018 in | In distribution |
| 214042 | Slot Width.018 in | In distribution |
| 215006 | Slot Width.018 in | In distribution |
| 214058 | Slot Width.018 in | In distribution |
| 215005 | Slot Width.018 in | In distribution |
| 224013 | Slot Width.022 in | In distribution |
| 224010 | Slot Width.022 in | In distribution |
| 214026 | Slot Width.018 in | In distribution |
| 214035 | Slot Width.018 in | In distribution |
| 224015 | Slot Width.022 in | In distribution |
| 224035 | Slot Width.022 in | In distribution |
| 214027 | Slot Width.018 in | In distribution |
| 215002 | Slot Width.018 in | In distribution |
| 224054 | Slot Width.022 in | In distribution |
| 225004 | Slot Width.022 in | In distribution |
| 225006 | Slot Width.022 in | In distribution |
| 214046 | Slot Width.018 in | In distribution |
| 224001 | Slot Width.022 in | In distribution |
| 215003 | Slot Width.018 in | In distribution |
| 224042 | Slot Width.022 in | In distribution |
| 224034 | Slot Width.022 in | In distribution |
| 224004 | Slot Width.022 in | In distribution |
| 214044 | Slot Width.018 in | In distribution |
| 224012 | Slot Width.022 in | In distribution |
| 225002 | Slot Width.022 in | In distribution |
| 214005 | Slot Width.018 in | In distribution |
| 224003 | Slot Width.022 in | In distribution |
| 214013 | Slot Width.018 in | In distribution |
| 214014 | Slot Width.018 in | In distribution |
| 224006 | Slot Width.022 in | In distribution |
| 214033 | Slot Width.018 in | In distribution |
| 224050 | Slot Width.022 in | In distribution |
| 214047 | Slot Width.018 in | In distribution |
| 214043 | Slot Width.018 in | In distribution |
| 224002 | Slot Width.022 in | In distribution |
| 224031 | Slot Width.022 in | In distribution |
| 224038 | Slot Width.022 in | 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
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-02-08 | Class III | Packaging | Orthodontic brackets distributed was incorrectly labeled. | 124 | 2013-06-07 |
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.