MR
Band MR Mand 1ST Bicuspid SZ 27
27manufacturers in China registered for this device type
96catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (17), Jiangsu (4), Guangdong (4). 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| 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 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 27. All 27 manufacturers in China registered for Band, Preformed, Orthodontic
Record
| Listed by | American Orthodontics, United States |
|---|---|
| FDA product code | ECM |
| Device type | Band, Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-06-10 |
| Record revised | 2025-01-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 470-0U-2700 | In distribution | |
| 570-0U-1200 | In distribution | |
| 570-0U-1400 | In distribution | |
| 560-0U-0400 | In distribution | |
| 570-0U-0500 | In distribution | |
| 470-0U-1100 | In distribution | |
| 570-0U-0700 | In distribution | |
| 470-0U-2200 | In distribution | |
| 560-0U-2900 | In distribution | |
| 470-0U-2800 | In distribution | |
| 570-0U-0800 | In distribution | |
| 560-0U-0100 | In distribution | |
| 470-0U-1900 | In distribution | |
| 470-0U-3000 | In distribution | |
| 570-0U-2000 | In distribution | |
| 560-0U-2400 | In distribution | |
| 470-0U-1200 | In distribution | |
| 570-0U-0300 | In distribution | |
| 560-0U-1100 | In distribution | |
| 570-0U-2700 | In distribution | |
| 470-0U-2600 | In distribution | |
| 470-0U-0900 | In distribution | |
| 470-0U-0400 | In distribution | |
| 560-0U-2100 | In distribution | |
| 470-0U-0500 | In distribution | |
| 560-0U-0900 | In distribution | |
| 560-0U-3200 | In distribution | |
| 470-0U-2500 | In distribution | |
| 560-0U-1000 | In distribution | |
| 470-0U-0100 | In distribution | |
| 470-0U-1400 | In distribution | |
| 570-0U-2800 | In distribution | |
| 470-0U-0200 | In distribution | |
| 560-0U-0700 | In distribution | |
| 570-0U-0100 | In distribution | |
| 570-0U-2100 | In distribution | |
| 560-0U-2700 | In distribution | |
| 470-0U-1700 | In distribution | |
| 570-0U-0600 | In distribution | |
| 570-0U-2600 | In distribution | |
| 570-0U-1500 | In distribution | |
| 470-0U-2100 | In distribution | |
| 570-0U-0400 | In distribution | |
| 470-0U-1600 | In distribution | |
| 570-0U-1700 | In distribution | |
| 560-0U-2600 | In distribution | |
| 560-0U-3100 | In distribution | |
| 560-0U-1400 | In distribution | |
| 560-0U-1300 | In distribution | |
| 470-0U-0600 | In distribution | |
| 560-0U-3000 | In distribution | |
| 470-0U-1000 | In distribution | |
| 560-0U-1200 | In distribution | |
| 470-0U-2900 | In distribution | |
| 570-0U-2300 | In distribution | |
| 570-0U-3100 | In distribution | |
| 560-0U-1500 | In distribution | |
| 570-0U-2200 | In distribution | |
| 470-0U-1300 | In distribution | |
| 570-0U-3000 | In distribution | |
| 560-0U-2200 | In distribution | |
| 560-0U-0600 | In distribution | |
| 570-0U-1000 | In distribution | |
| 570-0U-0200 | In distribution | |
| 470-0U-2400 | In distribution | |
| 470-0U-2300 | In distribution | |
| 560-0U-1900 | In distribution | |
| 570-0U-1900 | In distribution | |
| 560-0U-0500 | In distribution | |
| 470-0U-0700 | In distribution | |
| 570-0U-1100 | In distribution | |
| 470-0U-2000 | In distribution | |
| 560-0U-2500 | In distribution | |
| 560-0U-0300 | In distribution | |
| 570-0U-0900 | In distribution | |
| 560-0U-1700 | In distribution | |
| 560-0U-1600 | In distribution | |
| 570-0U-3200 | In distribution | |
| 570-0U-2500 | In distribution | |
| 560-0U-1800 | In distribution | |
| 470-0U-3100 | In distribution | |
| 470-0U-0300 | In distribution | |
| 560-0U-0800 | In distribution | |
| 570-0U-2900 | In distribution | |
| 570-0U-1800 | In distribution | |
| 570-0U-2400 | In distribution | |
| 560-0U-2000 | In distribution | |
| 470-0U-3200 | In distribution | |
| 570-0U-1600 | In distribution | |
| 560-0U-2800 | In distribution | |
| 560-0U-0200 | In distribution | |
| 570-0U-1300 | In distribution | |
| 470-0U-1500 | In distribution | |
| 560-0U-2300 | In distribution | |
| 470-0U-1800 | In distribution | |
| 470-0U-0800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Band, Preformed, Orthodontic | Forestadent Bernhard Förster GmbH | 8,646 |
| TruFit 2.0 | Ortho Technology, Inc. | 4,890 |
| TruFit™ | Ortho Organizers, Inc. | 3,943 |
| Leone SPA | Leone SPA | 2,549 |
| dentaform® | Dentaurum GmbH & Co. KG | 1,763 |
| Band Assemblies | Ortho Organizers, Inc. | 1,642 |
| 3M™ Victory Series™ | 3M Unitek | 1,388 |
| The Orthodontic Store | Young Innovations Inc. | 925 |
| Elite® Band Assemblies | Ortho Organizers, Inc. | 924 |
| TruFit™ 2.0 | Ortho Organizers, Inc. | 916 |
| 3M™ Unitek™ | 3M Unitek | 771 |
| Elite | Ortho Organizers, Inc. | 722 |
Showing 12 of 154. All products under Band, Preformed, 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.