Mini Standard Edgewise
DB BKT Mini Standard Edgewise UL/LR Cusp 022 T=0 A=0 R=0 W/HK Dist
52manufacturers in China registered for this device type
31catalogue numbers in this listing
22510(k) clearances naming this product code
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 | American Orthodontics, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-06 |
| Record revised | 2025-06-18 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 380-0024BL | In distribution | |
| 380-0024 | In distribution | |
| 380-0023BL | In distribution | |
| 380-0021BL | In distribution | |
| 380-0007 | In distribution | |
| 380-0022BR | In distribution | |
| 380-0002HDUR | In distribution | |
| 380-0023BR | In distribution | |
| 380-0022BL | In distribution | |
| 380-032272 | In distribution | |
| 380-0028BR | In distribution | |
| 380-0002HDUL | In distribution | |
| 380-0006 | In distribution | |
| 380-0008 | In distribution | |
| 380-0002 | In distribution | |
| 380-0003BL | In distribution | |
| 380-0024BR | In distribution | |
| 380-0021BR | In distribution | |
| 380-0021 | In distribution | |
| 380-0028BL | In distribution | |
| 380-0004BR | In distribution | |
| 380-0028 | In distribution | |
| 380-0023 | In distribution | |
| 380-0022 | In distribution | |
| 380-0003 | In distribution | |
| 380-0004BL | In distribution | |
| 380-0003BR | In distribution | |
| 380-0001 | In distribution | |
| 380-0004 | In distribution | |
| 087-000 | Withdrawn | |
| 086-000 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K925012 | 1993-09-13 |
| K923261 | 1992-12-03 |
| K902064 | 1990-08-06 |
| K900488 | 1990-06-01 |
| K891331 | 1989-10-16 |
| K893482 | 1989-10-12 |
| K893655 | 1989-08-23 |
| K893483 | 1989-07-14 |
| K893555 | 1989-07-14 |
| K893550 | 1989-07-14 |
| K893484 | 1989-07-14 |
| K893654 | 1989-06-23 |
| K893549 | 1989-06-23 |
| K893542 | 1989-06-23 |
| K891775 | 1989-05-11 |
| K891599 | 1989-05-02 |
| K890536 | 1989-05-01 |
| K890656 | 1989-04-17 |
| K891484 | 1989-04-14 |
| K891592 | 1989-04-07 |
| K890581 | 1989-03-17 |
| K890145 | 1989-03-13 |
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.