3m™ Unitek™
3M™ Unitek™ Miniature Twin Metal Brackets Kit, MBT™ System 020-201, .018, U/L, Universal, 5X5, Cuspid/Bicuspid Hk, 20/Kit
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 | 3M Unitek, 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 | 2022-12-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 020-713 | 5 | In distribution | |
| 020-601 | 5 | In distribution | |
| 7017-222 | 10 | In distribution | |
| 7017-311 | 10 | In distribution | |
| 119-740 | 10 | In distribution | |
| 020-201 | 10 | In distribution | |
| 7017-209 | 10 | In distribution | |
| 7017-312 | 10 | In distribution | |
| 028-222 | 10 | In distribution | |
| 020-712 | 5 | In distribution | |
| 020-605 | 5 | In distribution | |
| 7017-211 | 10 | In distribution | |
| 020-705 | 5 | In distribution | |
| 7017-219 | 10 | In distribution | |
| 7017-321 | 10 | In distribution | |
| 119-765 | 10 | In distribution | |
| 028-309 | 5 | In distribution | |
| 7701-307 | 10 | In distribution | |
| 119-193 | In distribution | ||
| 7018-907 | 10 | In distribution | |
| 020-701 | 5 | In distribution | |
| 020-706 | 5 | In distribution | |
| 119-761 | 10 | In distribution | |
| 119-763 | 10 | In distribution | |
| 119-640 | 10 | In distribution | |
| 7017-224 | 10 | In distribution | |
| 119-635 | 10 | In distribution | |
| 020-606 | 5 | In distribution | |
| 119-172 | In distribution | ||
| 119-755 | 10 | In distribution | |
| 119-770 | 10 | In distribution | |
| 119-724 | 10 | In distribution | |
| 020-202 | 5 | In distribution | |
| 020-615 | 5 | In distribution | |
| 7017-319 | 10 | In distribution | |
| 020-711 | 5 | In distribution | |
| 7017-223 | 10 | In distribution | |
| 020-707 | 5 | In distribution | |
| 7017-212 | 10 | In distribution | |
| 028-325 | 5 | In distribution | |
| 7701-377 | 10 | In distribution | |
| 7017-220 | 10 | In distribution | |
| 7017-324 | 10 | In distribution | |
| 001-277 | 10 | In distribution | |
| 119-766 | 10 | In distribution | |
| 119-756 | 10 | In distribution | |
| 7017-322 | 10 | In distribution | |
| 020-702 | 5 | In distribution | |
| 020-704 | 5 | In distribution | |
| 020-708 | 5 | In distribution | |
| 119-726 | 10 | In distribution | |
| 119-768 | 10 | In distribution | |
| 001-234 | 10 | In distribution | |
| 001-280 | 10 | In distribution | |
| 119-723 | 10 | In distribution | |
| 020-604 | 5 | In distribution | |
| 119-762 | 10 | In distribution | |
| 119-163 | In distribution | ||
| 020-710 | 5 | In distribution | |
| 119-722 | 10 | In distribution | |
| 119-767 | 10 | In distribution | |
| 001-209 | 10 | In distribution | |
| 7018-912 | 10 | In distribution | |
| 7017-320 | 10 | In distribution | |
| 119-721 | 10 | In distribution | |
| 020-612 | 5 | In distribution | |
| 7017-323 | 10 | In distribution | |
| 020-603 | 5 | In distribution | |
| 028-319 | 5 | In distribution | |
| 119-711 | 10 | In distribution | |
| 001-233 | 10 | In distribution | |
| 028-221 | 10 | In distribution | |
| 020-709 | 5 | In distribution | |
| 020-715 | 5 | In distribution | |
| 020-714 | 5 | In distribution | |
| 001-237 | 10 | In distribution | |
| 119-764 | 10 | In distribution | |
| 020-602 | 5 | In distribution | |
| 119-735 | 10 | In distribution | |
| 119-769 | 10 | In distribution | |
| 020-703 | 5 | In distribution | |
| 7017-309 | 10 | In distribution | |
| 7017-221 | 10 | 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.